Clinical and Radiographic Evaluation of Mineral Trioxide Aggregate and Biodentine as Pulp Medicaments in Primary Molars
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 20, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 11, 2022
January 1, 2022
2 years
October 20, 2021
January 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
Direct Pulp Capping with Biodentine
EXPERIMENTALDirect Pulp Capping with Biodentine
Partial Pulpotomy with Biodentine
EXPERIMENTALPartial Pulpotomy with Biodentine
Pulpotomy with Biodentine
EXPERIMENTALPulpotomy with Biodentine
Direct Pulp Capping with MTA
EXPERIMENTALDirect Pulp Capping with MTA
Partial Pulpotomy with MTA
EXPERIMENTALPartial Pulpotomy with MTA
Pulpotomy with MTA
EXPERIMENTALPulpotomy with MTA
Interventions
Direct Pulp Capping
Partial Pulpotomy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- British University In Egyptlead
- Ain Shams Universitycollaborator
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Noha Kabil, Professor
British University In Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
October 20, 2021
First Posted
November 1, 2021
Study Start
April 1, 2020
Primary Completion
April 1, 2022
Study Completion
September 1, 2022
Last Updated
February 11, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share