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

British University In Egypt

Status: Unknown

Conditions: Pulp Disease, Dental

Treatments: Procedure: Direct Pulp Capping; Procedure: Partial Pulpotomy; Procedure: Pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05102318

Ain Shams University

Details and patient eligibility

About

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.

Full 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)

Enrollment: 150 estimated patients

Sex: All

Ages: 4 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 6 patient groups

Direct Pulp Capping with Biodentine

Experimental group

Description:

Direct Pulp Capping with Biodentine

Treatment:

Procedure: Direct Pulp Capping

Partial Pulpotomy with Biodentine

Experimental group

Description:

Partial Pulpotomy with Biodentine

Treatment:

Procedure: Partial Pulpotomy

Pulpotomy with Biodentine

Experimental group

Description:

Pulpotomy with Biodentine

Treatment:

Procedure: Pulpotomy

Direct Pulp Capping with MTA

Experimental group

Description:

Direct Pulp Capping with MTA

Treatment:

Procedure: Direct Pulp Capping

Partial Pulpotomy with MTA

Experimental group

Description:

Partial Pulpotomy with MTA

Treatment:

Procedure: Partial Pulpotomy

Pulpotomy with MTA

Experimental group

Description:

Pulpotomy with MTA

Treatment:

Procedure: Pulpotomy