Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars

• Sponsor: Tanta University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06020911
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

this study is aimed to conduct tomographic evaluation of reparative dentin bridges formed after indirect pulp capping with Biodentine and Theracal light cured. The null hypothesis of the study is that there will be no difference in the quantity and quality of reparative dentin formation between the tested materials used for the indirect pulp capping

Condition or Disease	Intervention/Treatment	Phase
Pulp Caping; Biodentine; Theracal	Drug: Biodentine; Drug: Theracal light cured	Phase 4

Detailed Description

Many materials have been used in indirect pulp capping for primary dentition. An ideal pulp capping material is to be successful when it is biocompatible, radiopaque, maintain good seal, protect the pulp against bacterial invasion in both long and short run, release sustained amounts of calcium ions, act as reservoir for calcium hydroxide and stimulate reparative dentin formation through inducing the pulp cells to form odontoblasts.

Theracal light cured is a light-cured resin modified calcium silicate (RMCS) used as an indirect pulp capping material. It releases more calcium ions than Mineral trioxide aggregate or dycal inducing reparative dentin and dentin bridge formation.Theracal light cured showed better sealing ability and less microleakage than Mineral trioxide aggregate and Biodentine

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Biodentine and Theracal Light-cured in Primary Molars
• Anticipated Study Start Date: Sep 10, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Biodentine 17 primary second molars of 17 children will be capped with Biodentine.	Drug: Biodentine; 17 primary second molars of 17 children will be capped with Biodentine
Active Comparator: Theracal light cured 17 primary second molars of 17 children will be capped with Theracal light cured	Drug: Theracal light cured; 17 primary second molars of 17 children will be capped with Theracal light cured

Outcome Measures

Primary Outcome Measures

1. Thickness of dentin in mm [UP to 9 months postoperatively]

   Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Thickness of dentin in mm

2. Radiodenisty in Hounsfield units [UP to 9 months postoperatively]

   Cone-beam computed tomography(CBCT) scan will be used after placing the capping material once at the start immediately postoperative after restoration and at the end of follow up period after 9 months to evaluate the Radiodenisty in Hounsfield units

3. pulp vitality [UP to 9 months postoperatively]

   The teeth in each group will be examined clinically after restoration and at the end of the follow up period using vitality tests. Treatment is considered to be successful when pulp remains vital with no signs of pain, no evidence of tooth mobility, normal tooth color, normal gingival health and presence of the restoration intact

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 7 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Each child has bilateral vital cavitated carious lesions in primary molars.

2. Positive vital pulp testing for both hot and cold response; is determined by ethyl chloride in cold pulp testing and heated gutta percha in hot pulp testing. Pain caused by these tests should not persist after the stimulus is removed.

3. Patient and parent cooperation.

4. Accessible isolation for the operated tooth with rubber dam.

5. primary molars with cavitated carious lesion on either occlusal or proximal surface that extend into the dentin .

6. Availability of remaining dentin thickness over the pulp.

7. Normal lamina dura and periodontal ligaments. 8 Absence of external and internal root resorption.

Exclusion Criteria:

1. Spontaneous pain, or persistent swelling or fistula.

2. Pain with percussion, presence of abscess and pathological mobility.

3. Uncooperative patient.

4. Progression of caries lesion to pulp and pulp exposure.

5. Presence of periapical lesion as abscess, cyst or granuloma.

6. Unhealthy bony tissues.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	El-garbia	Egypt	139

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Abd Elhameed Abd Elghany, Principle investigator Alaa Abd Elhameed Abd Elghany, Tanta University
• ClinicalTrials.gov Identifier: NCT06020911
• Other Study ID Numbers: R-PED-6-21-6
• First Posted: Sep 1, 2023
• Last Update Posted: Sep 1, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 1, 2023