Single and Two-visit Pulpectomy in Primary Molars
Clinical and Radiographic Evaluation of Single-Versus Two-visit Pulpectomy in Primary Molars: Randomized Controlled Clinical Trial
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
A total of 64 primary molars of 5-8 years old children will be randomly selected from Pediatric dental clinic at Faculty of Dentistry, Mansoura University. Children will have two bilateral carious primary molars indicated for pulpectomy ; One side will be treated in one visit and the other will be treated in two visits. Clinical and radiographic evaluation for 3 , 6, 12 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
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
First Submitted
Initial submission to the registry
October 1, 2023
CompletedStudy Start
First participant enrolled
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2024
CompletedOctober 6, 2023
October 1, 2023
3 months
October 1, 2023
October 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical and Radiographic outcomes
Proportion of clinical and radiographic success in both treatment protocols
3 , 6 and 12 months
Study Arms (2)
single visit
ACTIVE COMPARATORNecrotic primary molar treated in single visit
Two visits
ACTIVE COMPARATORNecrotic primary molar treated in two visits
Interventions
Comparison of clinical and radiographic outcome of Single and two visits pulpectomy
Eligibility Criteria
You may qualify if:
- Cooperative 5-8 years old children with no systemic diseases or chronic conditions. \_Every child should have bilateral necrotic primary molars indicated for pulpectomy with sufficient coronal tooth structure.
You may not qualify if:
- Children received antibiotics in the past month before the study. Primary molars with sinus tract, abscess, or facial cellulitis. Primary molas with root resorption exceeding one third of root length
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nadia Moustafa Fareag, Professor
Pediatric dentistry department. MANSOURA UNIVERSITY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sherbin/Dakhlia/Egypt
Study Record Dates
First Submitted
October 1, 2023
First Posted
October 6, 2023
Study Start
October 5, 2023
Primary Completion
January 5, 2024
Study Completion
October 5, 2024
Last Updated
October 6, 2023
Record last verified: 2023-10