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

Sponsor

British University In Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT05102318

Collaborator

Ain Shams University (Other)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental	Procedure: Direct Pulp Capping Procedure: Partial Pulpotomy Procedure: Pulpotomy	N/A

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):

Group 1(A): MTA Direct Pulp Capping. (n=25)
Group 1 (B): MTA Partial Pulpotomy. (n=25)
Group 1 (C): MTA Complete Pulpotomy. (n=25)

BiodentineTM Group (2):

Group 2(A): BiodentineTM Direct Pulp Capping. (n=25)
Group 2 (B): BiodentineTM Partial Pulpotomy. (n=25)
Group 2 (C): BiodentineTM Complete Pulpotomy. (n=25)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Direct Pulp Capping with Biodentine Direct Pulp Capping with Biodentine	Procedure: Direct Pulp Capping Direct Pulp Capping
Experimental: Partial Pulpotomy with Biodentine Partial Pulpotomy with Biodentine	Procedure: Partial Pulpotomy Partial Pulpotomy
Experimental: Pulpotomy with Biodentine Pulpotomy with Biodentine	Procedure: Pulpotomy Pulpotomy
Experimental: Direct Pulp Capping with MTA Direct Pulp Capping with MTA	Procedure: Direct Pulp Capping Direct Pulp Capping
Experimental: Partial Pulpotomy with MTA Partial Pulpotomy with MTA	Procedure: Partial Pulpotomy Partial Pulpotomy
Experimental: Pulpotomy with MTA Pulpotomy with MTA	Procedure: Pulpotomy Pulpotomy

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo		Egypt

Sponsors and Collaborators

British University In Egypt
Ain Shams University

Investigators

Study Director: Noha Kabil, Professor, British University In Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Magdy, Director, British University In Egypt

ClinicalTrials.gov Identifier:

NCT05102318

Other Study ID Numbers:

Ain Shams University

First Posted:

Nov 1, 2021

Last Update Posted:

Feb 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Marwa Magdy, Director, British University In Egypt

Direct pulp capping, Partial Pulpotomy, and Pulpotomy

Additional relevant MeSH terms:

Dental Pulp Diseases

Stomatognathic Diseases

Study Results

No Results Posted as of Feb 11, 2022