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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05102318
Other study ID # Ain Shams University
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2020
Est. completion date September 1, 2022

Study information

Verified date January 2022
Source British University In Egypt
Contact Marwa Magdy, PhD
Phone 00201007195996
Email marwa.magdy@bue.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 7 Years
Eligibility 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


Intervention

Procedure:
Direct Pulp Capping
Direct Pulp Capping
Partial Pulpotomy
Partial Pulpotomy
Pulpotomy
Pulpotomy

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (2)

Lead Sponsor Collaborator
British University In Egypt Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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
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