Clinical and Radiographic Success of Pulpotomy Using Neoputty Mineral Trioxide Aggregate Versus Pulpectomy Using Endoflas In Primary Molars With Irreversible Pulpitis: A Randomized Controlled Trial
1 other identifier
interventional
66
0 countries
N/A
Brief Summary
The goal of this randomized clinical trial is to evaluate the clinical and radiographic success of pulpotomy using Neoputty MTA vital primary molars diagnosed with symptomatic irreversible pulpitis. The main question it aims to answer is: Will Neoputty MTA pulpotomy have higher clinical and radiographic success in comparison to Endoflas pulpectomy in primary molars with irreversible pulpitis?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
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
April 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 10, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedApril 10, 2025
April 1, 2025
1 year
April 3, 2025
April 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain
postoperative pain will be assessed using the visual analogue scale (VAS) within 24 hours, after 1 week, 3, 6, 9, and 12 months. The patients are asked to point to the face that best represents how they are feeling at the follow-up visits.
within 24 hours, after 1 week, 3, 6, 9, and 12 months
Study Arms (2)
Neoputty MTA pulpotomy
EXPERIMENTALEndoflas pulpectomy
EXPERIMENTALInterventions
Neoputty MTA pulpotomy performed in vital primary molars with symptomatic irreversible pulpitis
Endoflas pulpectomy in vital primary molars with symptomatic irreversible pulpitis
Eligibility Criteria
You may qualify if:
- Children with spontaneous pain lasting a few seconds to several hours.
- Pain is intensified by thermal stimulus and persists after its removal.
- Pulp hemorrhage after performing access cavity and deroofing of pulp chamber showing reddish pink healthy pulp tissue.
- Radicular pulp health is verified by achieving hemostasis within six minutes of compression using a cotton pellet with 2% sodium hypochlorite.
- Absence of peri-apical or inter-radicular radiolucency, widening of periodontal ligament space, internal or external root resorption.
You may not qualify if:
- Unrestorable primary molars.
- Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Officials
- PRINCIPAL INVESTIGATOR
DR
assistant lecturer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR.
Study Record Dates
First Submitted
April 3, 2025
First Posted
April 10, 2025
Study Start
May 1, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share