New Vital Pulpotomy Medications in Primary Molars

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05937100

Collaborator

(none)

Enrollment

Location

Arms

18.1

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate clinically and radiographically the effect of biodentine and hyaluronic acid (HA) versus formocresol (FC) as pulpotomy medications in primary molars.

Condition or Disease	Intervention/Treatment	Phase
Carious Exposure of Pulp	Drug: Formocresol Drug: Biodentine Drug: Hyaluronic acid gel	N/A

Detailed Description

Split mouth randomized controlled clinical trial. This study will be conducted on 96 teeth from 48 children in age group 4-7 years and have bilateral lower primary molars indicated for vital pulpotomy procedure. for:

Clinical evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.
Radiographic evaluation of biodentine, hyaluronic acid and formocresol groups according to presence of failure criteria at different follow up periods.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

the observer and the recipients will be blinded to the study group to avoid bias (double blind randomized controlled trial)

Primary Purpose:

Treatment

Official Title:

Clinical and Radiographic Evaluation of Hyaluronic Acid and Biodentine as Vital Pulpotomy Medications in Primary Molars: Randomized Controlled Clinical Trial

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control: Formocresol Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.	Drug: Formocresol Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute
Experimental: Group A : (Biodentine) The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.	Drug: Biodentine Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps
Experimental: Group B : (Hyaluronic acid gel) Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.	Drug: Hyaluronic acid gel Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.

Arm

Intervention/Treatment

Active Comparator: control: Formocresol

Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute then removed and pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.

Drug: Formocresol

Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Teeth will be treated by using squeezed sterile cotton pellet with 20% formcresol for 1 minute

Experimental: Group A : (Biodentine)

The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps, and allowed to set.

Drug: Biodentine

Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.The biodentine mix will be prepared according to the manufacturer's instructions and condensed lightly with a condenser on the pulp stumps

Experimental: Group B : (Hyaluronic acid gel)

Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes. Then the pulp stumps will be dressed with a layer of zinc oxide-eugenol (ZOE) paste.

Drug: Hyaluronic acid gel

Molars will be anesthetized by local anesthesia. The rubber dam will be used for isolation. Caries will be removed by large spoon excavator. When pulpal exposure occurs, deroofing of the pulp chamber will be achieved then pulpal tissue will be amputated using sharp excavator. Hemostasis will be obtained by applying pressure with saline moist cotton pellet. If bleeding has not stopped within 5 min, tooth will be excluded from the study.Hyaluronic acid gel will be compressed against the amputated pulp for 5 minutes.

Outcome Measures

Primary Outcome Measures

clinically successful pulpotomy [18 months]
Pain symptom - free teeth on percussion as well as during mastication. Absence of pathological tooth mobility. Absence of swelling of pulpal origin. . Absence of sinus tract.
radiographically successful pulpotomy [18 months]
No internal or external root resorption. No periapical or furcation radiolucency. No widening of periodontal ligament space.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

-Clinical criteria

Restorable mandibular primary molars with deep carious lesions.
Absence of gingival swelling or sinus tract.
Absence of spontaneous pain
Absence of pain on percussion. B-Radiographic Criteria: Absence of
Discontinuity of lamina dura
Internal root resorption.
External root resorption.
inter-radicular or periapical bone destruction (radiolucency)

Exclusion Criteria:

Excessive bleeding during pulp amputation.
Non vital/necrotic teeth.
Any sort of medical history contraindicating the pulp treatment.
Teeth approximate exfoliation
Patient's guardians are not intending to be part of the study.
Retreatment of previously pulpotomy treated molar -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dentistry	Mansoura		Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Weaam I El-tantawy, assistant lecturer ,Faculty of Dentistry, Mansoura University B.D.S (2016)
Study Director: Nadia M Farrag, Professor ,Faculty of Dentistry, Mansoura University
Study Director: Hossam E Hammouda, Lecturer, Faculty of Dentistry, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weaam ibrahiem eltantawy, assistant lecturer at pediatric department-Mansoura University, Mansoura University

ClinicalTrials.gov Identifier:

NCT05937100

Other Study ID Numbers:

A0103023PP

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 10, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Weaam ibrahiem eltantawy, assistant lecturer at pediatric department-Mansoura University, Mansoura University

Hyaluronic Acid - Biodentine - Pulpotomy

Additional relevant MeSH terms:

Hyaluronic Acid

Study Results

No Results Posted as of Jul 10, 2023