Evaluation of Hyaluronic Acid Pulpotomies in Primary Molars

• Sponsor: Marmara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04115358
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry, Department of Pediatric Dentistry will be subjected to pulpotomy treatments. After proper diagnosis of coronal pulpitis, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol (FC) pulpotomy treatments, 40 primary molars for ferric sulfate (FS) treatments and 40 primary molars for 0.5% hyaluronic acid gel (HA) pulpotomy treatments. The tooth decay will be removed, the pulp will be amputated from the chamber of the pulp with a sharp excavator and one of the medicament will be applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide cement, and the primary molars will be restored with a composite filling material or with a stainless steel crown (SSC). A single investigator will perform the procedure. The teeth will be followed clinically and radiographically at 1st, 3rd, 6th, 12th months.

Condition or Disease	Intervention/Treatment	Phase
Pulpitis	Procedure: Hyaluronic acid: Gengigel teething; Procedure: Formocresol Buckley formula: Formacresol; Procedure: Ferric sulfate: ViscoStat	N/A

Detailed Description

The aim of this study is to compare the efficacy of the materials used in pulpotomies, and to evaluate the success of hyaluronic gel over the formocresol and/or ferric sulfate considered as the gold standard for this type of treatment.

Pulpotomy is an endodontic treatment method aiming to maintain primary molar affected from deep caries and acute pulpitis by removing the effected pulpal tissue, leaving the remaining root canal pulp and maintaining its vitality and function until the tooth exfoliates physiologically. In order to remain canals intact and uninflamed various dental materials are used according to treatment purposes; categorized into three groups as devitalizing, preventive and regenerative treatment.

1. Devitalization: Formocresol, Glutaraldehyde, Electro-surgery

2. Protective: Ferric Sulfate, Calcium Hydroxide, Mineral Trioxide Aggregate, Lasers

3. Regenerative: Bone Morphogenetic Protein, Enriched Collagen

The ideal agent or method for pulpotomy treatment of the primary teeth has not been determined yet but the earliest method of diluted formocresol is considered by many the gold standard. Formocresol is a strong strain that fixes living tissues. It contains formaldehyde gas, organic structures, dentin channels and narrow side channels until the bacteria are also fixed. 10% formalin solution (14% formaldehyde) is used as a tissue fixative.

Ferric Sulfate an other material for pulpotomy is used in dentistry mainly as a hemostatic agent. It has several advantages over formocresol such as non-mutagenic property and keeping root canal pulp vital.

Hyaluronic acid gel, which is a new product as a pulpotomy material, has been used in dentistry as well as medicine for many years. It is distributed widely in epithelial and connective tissues. Medical uses include joint treatments, skin lotions for atopic dermatitis, cosmetic surgery etc. In dentistry, gingivitis, teething, dental surgery including implants and sinus lifting procedures and oral ulcers are main target for hyaluronic acid treatment. This study extends the use of hyaluronic acid to primary tooth endodontics.

In this study, 120 primary molar teeth from healthy children aged between 5 and 9 and who apply to Marmara University Faculty of Dentistry Department of Pediatric Dentistry will be subjected to pulpotomy treatments. Sample size calculation showed that at first 40 teeth in each group will be required to detect a significant difference (80% power, two-sided 5% significance level).

Ethical approval of the study was taken from the Clinical Research Ethics Committee, Faculty of Dentistry at Marmara University (No: 2019/288) in accordance with the Declaration of Helsinki. The patients' family will be given information about the pros and cons of the study on the relevant teeth and then a written consent will be obtained.

Patients will be selected for this study according to the following criteria:

1. Children who have good cooperation, do not require general anesthesia or sedation, and who do not have any systemic disease, allergic reactions, or any use of medications.

2. No spontaneous, continuous pain in the tooth, no pathological or physiological mobility, no abscess and/or fistula, no tenderness to palpation or percussion.

3. The tooth can be restored with a stainless steel crown (SSC) or a composite filling material after treatment.

4. The physiological resorption in the tooth root not exceeding 1/3.

5. No pathological resorption in the tooth root canals internally and/or externally, no radiolucency in the periapical or furcation regions, no enlargement of periodontal ligaments.

Exclusion criteria:

1. Children who have any disorders, spontaneous pain, no restorable primary molars, may exfoliate soon and teeth with apical periodontitis, pulp necrosis, abscess, fistula, swelling or mobility.

2. Families who are not willing to join the study.

After proper diagnosis of coronal pulpitis, local anesthesia is administrated, the teeth will be assigned randomly to one of the 3 groups: 40 primary molars for formocresol pulpotomy treatments, 40 primary molars for ferric sulfate treatments and 40 primary molars for 0.5% hyaluronic acid gel pulpotomy treatments. The tooth decay is removed, the roof of the pulp chamber is removed by joining the pulp horns with a bur cut. The coronal pulp is amputated from the chamber of the pulp with a sharp excavator and one or more cotton pellets is placed over the site and pressure is applied. When the hemostasis is insured, one of the medicament is applied to the orifice of the root canals. The cavity will be sealed tight with zinc oxide eugenol cement. The primary molars were restored either with a stainless-steel crown in case of proximal cavities or with a composite filling material in case of occlusal cavities. A single pediatric dentist will perform whole pulpotomy treatments and restorations of all selected teeth. The teeth will be followed clinically and radiographically at 1, 3, 6, 12 months.

The teeth will be evaluated clinically and radiographically according to the following criteria:

1. Clinical criteria: Spontaneous pain, tenderness to percussion and/or palpation, pathological mobility and abscess or fistula.

2. Radiographic criteria: Periapical or furcal radiolucency, internal or external root resorption, loss of lamina dura.

All evaluations will be performed by two calibrated pediatric dentists. The performing dentist will not be blinded to the treatment materials but the patient and two examiners who evaluated clinical and radiographic findings will be blinded to the treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiographic Evaluation of Formocresol, Ferric Sulfate and Hyaluronic Acid Pulpotomies on Human Primary Teeth: A Randomized Controlled Clinical Trial
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Sep 1, 2020
• Actual Study Completion Date: Oct 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hyaluronic acid Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar.	Procedure: Hyaluronic acid: Gengigel teething; Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
Active Comparator: Formocresol 0,1 ml to the orifice of the root canals of the primary molar.	Procedure: Formocresol Buckley formula: Formacresol; Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
Active Comparator: Ferric sulfate 0,1 ml to the orifice of the root canals of the primary molar.	Procedure: Ferric sulfate: ViscoStat; Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.

Outcome Measures

Primary Outcome Measures

1. Number of Teeth Sensitive to Percussion in 3 Groups [Change from Baseline at 1 month in 3 groups]

   Sensitivity to biting, chewing and clinically to the percussion by a probe

2. Number of Teeth Sensitive to Percussion in 3 Groups [Change from Baseline at 3 months in 3 groups]

   Sensitivity to biting, chewing and clinically to the percussion by a probe

3. Number of Teeth Sensitive to Percussion in 3 Groups [Change from Baseline at 6 months in 3 groups]

   Sensitivity to biting, chewing and clinically to the percussion by a probe

4. Number of Teeth Sensitive to Percussion in 3 Groups [Change from Baseline at 12 months in 3 groups]

   Sensitivity to biting, chewing and clinically to the percussion by a probe

5. Number of Mobile Teeth in 3 Groups [Change from Baseline at 1 month in 3 groups]

   Mobility of the treated tooth and/or the tooth is sensitive to the vibration

6. Number of Mobile Teeth in 3 Groups [Change from Baseline at 3 month in 3 groups]

   Mobility of the treated tooth and/or the tooth is sensitive to the vibration

7. Number of Mobile Teeth in 3 Groups [Change from Baseline at 6 month in 3 groups]

   Mobility of the treated tooth and/or the tooth is sensitive to the vibration

8. Number of Mobile Teeth in 3 Groups [Change from Baseline at 12 months in 3 groups]

   Mobility of the treated tooth and/or the tooth is sensitive to the vibration

9. Number of Teeth With Patient Discomfort and/or Pain in 3 Groups [Change from Baseline at 1 month in 3 groups]

   Any pain history at that time frame and/or complaint of discomfort and pain clinically

10. Number of Teeth With Patient Discomfort and/or Pain in 3 Groups [Change from Baseline at 3 months in 3 groups]

    Any pain history at that time frame and/or complaint of discomfort and pain clinically

11. Number of Teeth With Patient Discomfort and/or Pain in 3 Groups [Change from Baseline at 6 months in 3 groups]

    Any pain history at that time frame and/or complaint of discomfort and pain clinically

12. Number of Teeth With Patient Discomfort and/or Pain in 3 Groups [Change from Baseline at 12 months in 3 groups]

    Any pain history at that time frame and/or complaint of discomfort and pain clinically

13. Number of Teeth With Dental Abscess in 3 Groups [Change from Baseline at 1 month in 3 groups]

    Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically

14. Number of Teeth With Dental Abscess in 3 Groups [Change from Baseline at 3 months in 3 groups]

    Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically

15. Number of Teeth With Dental Abscess in 3 Groups [Change from Baseline at 6 months in 3 groups]

    Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically

16. Number of Teeth With Dental Abscess in 3 Groups [Change from Baseline at 12 months]

    Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically

17. Number of the Pathological Exfoliation of Affected Teeth in 3 Groups [Change from Baseline at 1 month in 3 groups]

    The tooth is missing or ready to exfoliate physiologically and no pathology is examined

18. Number of the Pathological Exfoliation of Affected Teeth in 3 Groups [Change from Baseline at 3 months in 3 groups]

    The tooth is missing or ready to exfoliate physiologically and no pathology is examined

19. Number of the Pathological Exfoliation of Affected Teeth in 3 Groups [Change from Baseline at 6 months in 3 groups]

    The tooth is missing or ready to exfoliate physiologically and no pathology is examined

20. Number of the Pathological Exfoliation of Affected Teeth in 3 Groups [Change from Baseline at 12 months in 3 groups]

    The tooth is missing or ready to exfoliate physiologically and no pathology is examined

21. Number of Teeth With Root Resorption in 3 Groups [Change from Baseline at 1 month in 3 groups]

    Internal, external, early or physiological root resorption from periapical/panoramic radiographs

22. Number of Teeth With Root Resorption in 3 Groups [Change from Baseline at 3 months in 3 groups]

    Internal, external, early or physiological root resorption from periapical/panoramic radiographs

23. Number of Teeth With Root Resorption in 3 Groups [Change from Baseline at 6 months]

    Internal, external, early or physiological root resorption from periapical/panoramic radiographs

24. Number of Teeth With Root Resorption in 3 Groups [Change from Baseline at 12 months]

    Internal, external, early or physiological root resorption from periapical/panoramic radiographs

25. Number of Teeth With Any Root Lesion From Radiography in 3 Groups [Change from Baseline at 1 month in 3 groups]

    Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration

26. Number of Teeth With Any Root Lesion From Radiography in 3 Groups [Change from Baseline at 3 months in 3 groups]

    Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration

27. Number of Teeth With Any Root Lesion From Radiography in 3 Groups [Change from Baseline at 6 months in 3 groups]

    Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration

28. Number of Teeth With Any Root Lesion From Radiography in 3 Groups [Change from Baseline at 12 months in 3 groups]

    Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration

Secondary Outcome Measures

1. Restoration Stability [Change from Baseline at 1 month]

   The survival rate of stainless steel crown and composite applied to each pulpotomized tooth

2. Restoration Stability [Change from Baseline at 3 months]

   The survival rate of stainless steel crown and composite applied to each pulpotomized tooth

3. Restoration Stability [Change from Baseline at 6 months]

   The survival rate of stainless steel crown and composite applied to each pulpotomized tooth

4. Restoration Stability [Change from Baseline at 12 months]

   The survival rate of stainless steel crown and composite applied to each pulpotomized tooth

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• No systemic disease,

• No pathological mobility and/or resorption of the tooth,

• No pain and/or abscess,

• Parents volunteering,

• The patients are between 5-9 years old.

Exclusion Criteria:

• Systemic disease,

• Pathological mobility and resorption of the tooth,

• Pain and/or abscess,

• Non voluntary,

• The patients aren't between 5-9 years old.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University, Faculty of Dentistry, Department of Pediatric Dentistry	Istanbul		Turkey	34854

Sponsors and Collaborators

• Marmara University

Investigators

• Principal Investigator: Ali Mentes, Prof, Marmara University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 1, 2019

More Information

Publications

None provided.

• Responsible Party: Marmara University
• ClinicalTrials.gov Identifier: NCT04115358
• Other Study ID Numbers: MarmaraPD
• First Posted: Oct 4, 2019
• Last Update Posted: Aug 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marmara University: Pulpotomy
• Additional relevant MeSH terms: Pulpitis; Hyaluronic Acid

Study Results

Participant Flow

Recruitment Details

The first participant was enrolled in May 2019 and the last participant was enrolled in September 2019. No important changes in methods or selection criteria have been done. 1st, 3rd and 6th months assessments were made without complications but 1-year examination had some face to face problems with the Covid-19 pandemics. So some final examinations and patient comforts had been done via phone and/or online connections.

Pre-assignment Detail

The study was initially carried out on 136 primary molars of 47 children. Three children (2 boys, 1 girl) did not show up in any recalls, so the study was performed in 130 primary molars.

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.	0,1 ml to the orifice of the root canals of the primary molar. Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.	0,1 ml to the orifice of the root canals of the primary molar. Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown and composite filling material.
Period Title: Overall Study
STARTED	34	33	34
COMPLETED	34	33	33
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate	Total
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar. Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns (SSC) and composite filling material.	Total of all reporting groups
Overall Participants	34	33	34	101
Overall tooth	51	40	39	130
Age (Count of Participants)
<=18 years	34 100%	33 100%	34 100%	101 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	6.65 (0.99)	6.83 (0.98)	6.67 (1.08)	6.71 (1.015)
Sex: Female, Male (tooth) [Count of Units]
Female	32	25	23	80
Male	19	15	16	50
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Turkey	34 100%	33 100%	34 100%	101 100%
Dental Arch/Tooth Type (tooth) [Count of Units]
Maxillary 1st primary molars	11	9	7	27
Maxillary 2nd primary molars	17	13	8	38
Mandibular 1st primary molars	14	11	15	40
Mandibular 2nd primary molars	9	7	9	25
Dental Arch (tooth) [Count of Units]
Lower Arch	23	18	24	65
Upper Arch	28	22	15	65
Tooth Type (tooth) [Count of Units]
1st primary molars	25	20	22	67
2nd primary molars	26	20	17	63
Final Restoration (tooth) [Count of Units]
SSC	33	28	28	89
Composite	18	12	11	41

Outcome Measures

1. Primary Outcome

Title	Number of Teeth Sensitive to Percussion in 3 Groups
Description	Sensitivity to biting, chewing and clinically to the percussion by a probe
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	7	6	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

2. Primary Outcome

Title	Number of Teeth Sensitive to Percussion in 3 Groups
Description	Sensitivity to biting, chewing and clinically to the percussion by a probe
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth is extracted in HA group so 50 teeth are evaluated

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	10	8	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

3. Primary Outcome

Title	Number of Teeth Sensitive to Percussion in 3 Groups
Description	Sensitivity to biting, chewing and clinically to the percussion by a probe
Time Frame	Change from Baseline at 6 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated in FS group and 1 participant so no observation for 1 tooth and 1 participant in FS

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	11	8	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

4. Primary Outcome

Title	Number of Teeth Sensitive to Percussion in 3 Groups
Description	Sensitivity to biting, chewing and clinically to the percussion by a probe
Time Frame	Change from Baseline at 12 months in 3 groups

Outcome Measure Data

Analysis Population Description

2 teeth exfoliated from HA group (not participants) so number of teeth reduced from 50 to 48

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	48	40	38
Count of Units [teeth]	2	6	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

5. Primary Outcome

Title	Number of Mobile Teeth in 3 Groups
Description	Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	1	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

6. Primary Outcome

Title	Number of Mobile Teeth in 3 Groups
Description	Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Time Frame	Change from Baseline at 3 month in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth extracted from HA group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	1	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

7. Primary Outcome

Title	Number of Mobile Teeth in 3 Groups
Description	Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Time Frame	Change from Baseline at 6 month in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated from FS group (1 participant ) so 1 child and 1 tooth is reduced from FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	3	2	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

8. Primary Outcome

Title	Number of Mobile Teeth in 3 Groups
Description	Mobility of the treated tooth and/or the tooth is sensitive to the vibration
Time Frame	Change from Baseline at 12 months in 3 groups

Outcome Measure Data

Analysis Population Description

2 teeth exfoliated from HA group (not participants) so 50 teeth reduced to 48 teeth but participants still exist

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	48	40	38
Count of Units [teeth]	4	4	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

9. Primary Outcome

Title	Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Description	Any pain history at that time frame and/or complaint of discomfort and pain clinically
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	1	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

10. Primary Outcome

Title	Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Description	Any pain history at that time frame and/or complaint of discomfort and pain clinically
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth extracted from HA group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

11. Primary Outcome

Title	Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Description	Any pain history at that time frame and/or complaint of discomfort and pain clinically
Time Frame	Change from Baseline at 6 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated (one participant) so 1 tooth and 1 participant are reduced from FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

12. Primary Outcome

Title	Number of Teeth With Patient Discomfort and/or Pain in 3 Groups
Description	Any pain history at that time frame and/or complaint of discomfort and pain clinically
Time Frame	Change from Baseline at 12 months in 3 groups

Outcome Measure Data

Analysis Population Description

2 teeth exfoliated in HA group so 50 teeth reduced to 48 but no participant is reduced

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	48	40	38
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

13. Primary Outcome

Title	Number of Teeth With Dental Abscess in 3 Groups
Description	Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	1	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

14. Primary Outcome

Title	Number of Teeth With Dental Abscess in 3 Groups
Description	Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

15. Primary Outcome

Title	Number of Teeth With Dental Abscess in 3 Groups
Description	Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Time Frame	Change from Baseline at 6 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated in FS group so 1 tooth and 1 participant are reduced in FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

16. Primary Outcome

Title	Number of Teeth With Dental Abscess in 3 Groups
Description	Any sign of chronic pulpitis, redness or swelling of the gingiva and/or fistula at that time frame and clinically
Time Frame	Change from Baseline at 12 months

Outcome Measure Data

Analysis Population Description

2 teeth exfoliated from HA group so number of teeth reduced from 50 to 48 but participants are same

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	48	40	38
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

17. Primary Outcome

Title	Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Description	The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	0	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

18. Primary Outcome

Title	Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Description	The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	1	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

19. Primary Outcome

Title	Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Description	The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Time Frame	Change from Baseline at 6 months in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	0	0	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

20. Primary Outcome

Title	Number of the Pathological Exfoliation of Affected Teeth in 3 Groups
Description	The tooth is missing or ready to exfoliate physiologically and no pathology is examined
Time Frame	Change from Baseline at 12 months in 3 groups

Outcome Measure Data

Analysis Population Description

2 exfoliations in HA group are shown here

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	2	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

21. Primary Outcome

Title	Number of Teeth With Root Resorption in 3 Groups
Description	Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Periapical resorption	1	1	2
Internal resorption	6	4	1
External resorption	1	0	1
No resorption	43	35	35

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

22. Primary Outcome

Title	Number of Teeth With Root Resorption in 3 Groups
Description	Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth extracted in HA group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Periapical resorption	2	3	4
Internal resorption	9	11	6
External resorption	6	1	3
No resorption	33	25	26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

23. Primary Outcome

Title	Number of Teeth With Root Resorption in 3 Groups
Description	Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Time Frame	Change from Baseline at 6 months

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced in FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Periapical resorption	7	5	5
Internal resorption	11	12	10
External resorption	5	5	5
No resorption	27	18	18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

24. Primary Outcome

Title	Number of Teeth With Root Resorption in 3 Groups
Description	Internal, external, early or physiological root resorption from periapical/panoramic radiographs
Time Frame	Change from Baseline at 12 months

Outcome Measure Data

Analysis Population Description

6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	28	26	26
Measure teeth	35	32	31
Periapical resorption	12	8	15
Internal resorption	11	8	5
External resorption	7	6	5
No resorption	5	10	6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

25. Primary Outcome

Title	Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Description	Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Time Frame	Change from Baseline at 1 month in 3 groups

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Count of Units [teeth]	3	1	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

26. Primary Outcome

Title	Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Description	Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Time Frame	Change from Baseline at 3 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth is extracted in HA group so 1 tooth is reduced but not participant

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Count of Units [teeth]	7	3	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

27. Primary Outcome

Title	Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Description	Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Time Frame	Change from Baseline at 6 months in 3 groups

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated in FS group so 1 tooth and 1 participant are not evaluated in FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Count of Units [teeth]	4	4	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

28. Primary Outcome

Title	Number of Teeth With Any Root Lesion From Radiography in 3 Groups
Description	Radiographic evaluation for any periapical or bifurcal lesion, cyst formation or obliteration
Time Frame	Change from Baseline at 12 months in 3 groups

Outcome Measure Data

Analysis Population Description

6 participants, 12 teeth missing for xrays, 2 exfoliations from HA group; 7 participants, 8 teeth missing for xrays from FC group; 7 participants, 7 teeth missing for xrays from FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	28	26	26
Measure teeth	35	32	31
Count of Units [teeth]	4	4	2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

29. Secondary Outcome

Title	Restoration Stability
Description	The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Time Frame	Change from Baseline at 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	51	40	39
Stainless steel crown	33	28	28
Composite	18	12	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

30. Secondary Outcome

Title	Restoration Stability
Description	The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Time Frame	Change from Baseline at 3 months

Outcome Measure Data

Analysis Population Description

1 tooth extracted from HA group so reduced to 50 teeth but no participant reduction

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	34
Measure teeth	50	40	39
Stainless steel crown	32	28	28
Composite	18	12	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

31. Secondary Outcome

Title	Restoration Stability
Description	The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Time Frame	Change from Baseline at 6 months

Outcome Measure Data

Analysis Population Description

1 tooth exfoliated from FS group so 1 tooth and 1 participant reduced from FS group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	50	40	38
Stainless steel crown	32	28	27
Composite	18	12	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

32. Secondary Outcome

Title	Restoration Stability
Description	The survival rate of stainless steel crown and composite applied to each pulpotomized tooth
Time Frame	Change from Baseline at 12 months

Outcome Measure Data

Analysis Population Description

2 teeth exfoliated from HA group so 50 teeth reduced to 48 teeth in HA group

Arm/Group Title	Hyaluronic Acid	Formocresol	Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.	0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
Measure Participants	34	33	33
Measure teeth	48	40	38
Stainless steel crown	31	28	27
Composite	17	12	11

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hyaluronic Acid, Formocresol, Ferric Sulfate
	Comments	Chi-Square Test was used to compare qualitative data.The results were evaluated at the significance level of p<0,05.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Overall study;1st month,3rd month,6th month and 12th month after the treatments
Adverse Event Reporting Description	pain or discomfort may be seen after the treatment of the primary tooth tooth can be exfoliated prematurely
Arm/Group Title	Hyaluronic Acid		Formocresol		Ferric Sulfate
Arm/Group Description	Gengigel teething (%0,54 hyaluronic acid), 0,1ml to the orifice of the root canals of the primary molar Hyaluronic acid: Gengigel teething: Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.		0,1 ml to the orifice of the root canals of the primary molar Formocresol Buckley formula: Formacresol: Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.		0,1 ml to the orifice of the root canals of the primary molar Ferric sulfate: ViscoStat: Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crown or composite filling material.
All Cause Mortality
	Hyaluronic Acid		Formocresol		Ferric Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/34 (0%)
Serious Adverse Events
	Hyaluronic Acid		Formocresol		Ferric Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Hyaluronic Acid		Formocresol		Ferric Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/33 (0%)		0/34 (0%)
Infections and infestations
pulpitis	0/34 (0%)	0	0/33 (0%)	0	0/34 (0%)	0

Limitations/Caveats

The limitations of this study included the unfortunate Covid-19 pandemic that interfered with the radiographic results of our study at 12th month, 8 participants did not show up to the dental appointments at 12th month and complicated the follow-up results on radiographs. However we managed to do the clinical examinations of all patients via social video conferencing devices (teledentistry).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.