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

NCT ID: NCT06020911

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-10-01

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

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

Conditions

Pulp Caping; Biodentine; Theracal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biodentine

17 primary second molars of 17 children will be capped with Biodentine.

Group Type: ACTIVE_COMPARATOR

Biodentine

Intervention Type: DRUG

17 primary second molars of 17 children will be capped with Biodentine

Theracal light cured

17 primary second molars of 17 children will be capped with Theracal light cured

Group Type: ACTIVE_COMPARATOR

Theracal light cured

Intervention Type: DRUG

17 primary second molars of 17 children will be capped with Theracal light cured

Interventions

Biodentine

17 primary second molars of 17 children will be capped with Biodentine

Intervention Type: DRUG

Theracal light cured

17 primary second molars of 17 children will be capped with Theracal light cured

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Abd Elhameed Abd Elghany

Principle investigator Alaa Abd Elhameed Abd Elghany

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-garbia, Egypt

Countries

Egypt

Other Identifiers

R-PED-6-21-6

Identifier Type: -

Identifier Source: org_study_id