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

Primary Purpose

Pulp Disease, Dental

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Direct Pulp Capping

Partial Pulpotomy

Pulpotomy

About this trial

This is an interventional treatment trial for Pulp Disease, Dental focused on measuring Direct pulp capping, Partial Pulpotomy, and Pulpotomy

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts 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.

Sites / Locations

Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Direct Pulp Capping with Biodentine

Partial Pulpotomy with Biodentine

Pulpotomy with Biodentine

Direct Pulp Capping with MTA

Partial Pulpotomy with MTA

Pulpotomy with MTA

Arm Description

Direct Pulp Capping with Biodentine

Partial Pulpotomy with Biodentine

Pulpotomy with Biodentine

Direct Pulp Capping with MTA

Partial Pulpotomy with MTA

Pulpotomy with MTA

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05102318

First Posted

October 20, 2021

Last Updated

January 28, 2022

Sponsor

British University In Egypt

Collaborators

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05102318

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British University In Egypt

Collaborators

Ain Shams University

4. Oversight

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

Data Monitoring Committee

5. 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulp Disease, Dental

Keywords

Direct pulp capping, Partial Pulpotomy, and Pulpotomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Direct Pulp Capping with Biodentine

Arm Type

Experimental

Arm Description

Direct Pulp Capping with Biodentine

Arm Title

Partial Pulpotomy with Biodentine

Arm Type

Experimental

Arm Description

Partial Pulpotomy with Biodentine

Arm Title

Pulpotomy with Biodentine

Arm Type

Experimental

Arm Description

Pulpotomy with Biodentine

Arm Title

Direct Pulp Capping with MTA

Arm Type

Experimental

Arm Description

Direct Pulp Capping with MTA

Arm Title

Partial Pulpotomy with MTA

Arm Type

Experimental

Arm Description

Partial Pulpotomy with MTA

Arm Title

Pulpotomy with MTA

Arm Type

Experimental

Arm Description

Pulpotomy with MTA

Intervention Type

Procedure

Intervention Name(s)

Direct Pulp Capping

Intervention Description

Direct Pulp Capping

Intervention Type

Procedure

Intervention Name(s)

Partial Pulpotomy

Intervention Description

Partial Pulpotomy

Intervention Type

Procedure

Intervention Name(s)

Pulpotomy

Intervention Description

Pulpotomy

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa Magdy, PhD

Phone

00201007195996

marwa.magdy@bue.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Nadia Metwalli, Professor

nadia.metwalli@bue.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noha Kabil, Professor

Organizational Affiliation

British University In Egypt

Official's Role

Study Director

Facility Information:

Facility Name

Ain Shams University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marwa Magdy, PhD

Phone

00201007195996

marwa.magdy@bue.edu.eg

First Name & Middle Initial & Last Name & Degree

Nadia Metwalli, Professor

nadia.metwalli@bue.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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