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

Pulp Disease, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05102318
• Other study ID #: Ain Shams University
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Pulp Disease, Dental
• Stomatognathic Diseases

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