Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars

Not Applicable

• Conditions: Pulp Disease, Dental
• Interventions: Procedure: Direct Pulp Capping; Procedure: Pulpotomy; Procedure: Partial Pulpotomy

• Registration Number: NCT05102318
• Lead Sponsor: British University In Egypt

Brief Summary

The aim of the present study is to evaluate Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

Detailed Description

Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database in Pediatric Dentistry department.

A total of 150 primary molars from healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain shams University.

Subjects will be assigned randomly into two different treatment groups as follows:

MTA Group (1):

1. Group 1(A): MTA Direct Pulp Capping. (n=25)

2. Group 1 (B): MTA Partial Pulpotomy. (n=25)

3. Group 1 (C): MTA Complete Pulpotomy. (n=25)

BiodentineTM Group (2):

1. Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)

2. Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)

3. Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-28
• Last Update Posted: 2022-02-11
• Primary Completion: 2022-04-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• No clinical symptoms or history implying irreversible pulpitis such as spontaneous pain, or pain persisting after stimuli removal.
• Absence of periapical or interadicular radiolucencies, inflammatory root resorption, sinus tract or gingival abscess.

Exclusion Criteria

• Children who are extremely uncooperative and difficult to manage.
• Children suffering from any physically or mentally disability that will complicate the treatment: Special Health Care needs (SHCN).
• Teeth of poor prognosis due to presence of an abscess or a sinus, mobility, advanced bone or root resorption or Non-Restorable teeth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Pulp Capping with MTA	Direct Pulp Capping	Direct Pulp Capping with MTA
Direct Pulp Capping with Biodentine	Direct Pulp Capping	Direct Pulp Capping with Biodentine
Pulpotomy with Biodentine	Pulpotomy	Pulpotomy with Biodentine
Partial Pulpotomy with MTA	Partial Pulpotomy	Partial Pulpotomy with MTA
Partial Pulpotomy with Biodentine	Partial Pulpotomy	Partial Pulpotomy with Biodentine
Pulpotomy with MTA	Pulpotomy	Pulpotomy with MTA

Primary Outcome Measures

Name	Time	Method
Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.	18 months	Is to evaluate the clinical and radiographic success rates of Mineral Trioxide Aggregate and Biodentine in direct pulp capping, partial pulpotomy, and pulpotomy in primary molars.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt