- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05102318
Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marwa Magdy, PhD
- Phone Number: 00201007195996
- Email: marwa.magdy@bue.edu.eg
Study Contact Backup
- Name: Nadia metwalli, professor
- Email: nadia.metwalli@bue.edu.eg
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- ain shams University
-
Contact:
- Marwa Magdy, PhD
- Phone Number: 00201007195996
- Email: marwa.magdy@bue.edu.eg
-
Contact:
- Nadia metwalli, professor
- Email: nadia.metwalli@bue.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Direct Pulp Capping with Biodentine
|
Direct Pulp Capping
|
Experimental: Partial Pulpotomy with Biodentine
|
Partial Pulpotomy
|
Experimental: Pulpotomy with Biodentine
|
Pulpotomy
|
Experimental: Direct Pulp Capping with MTA
|
Direct Pulp Capping
|
Experimental: Partial Pulpotomy with MTA
|
Partial Pulpotomy
|
Experimental: Pulpotomy with MTA
|
Pulpotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Noha Kabil, Professor, British University in Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ain Shams University (Faculty of Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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