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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Pulp Disease, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Direct Pulp Capping with Biodentine

Group Type EXPERIMENTAL

Direct Pulp Capping

Intervention Type PROCEDURE

Direct Pulp Capping

Partial Pulpotomy with Biodentine

Group Type EXPERIMENTAL

Partial Pulpotomy

Intervention Type PROCEDURE

Partial Pulpotomy

Pulpotomy with Biodentine

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

Pulpotomy

Direct Pulp Capping with MTA

Group Type EXPERIMENTAL

Direct Pulp Capping

Intervention Type PROCEDURE

Direct Pulp Capping

Partial Pulpotomy with MTA

Group Type EXPERIMENTAL

Partial Pulpotomy

Intervention Type PROCEDURE

Partial Pulpotomy

Pulpotomy with MTA

Group Type EXPERIMENTAL

Pulpotomy

Intervention Type PROCEDURE

Pulpotomy

Interventions

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Direct Pulp Capping

Intervention Type PROCEDURE

Partial Pulpotomy

Intervention Type PROCEDURE

Pulpotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes