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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 66
- Primary Endpoint
- postoperative pain
Study Overview
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?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Unrestorable primary molars.
- •Primary molars with uncontrolled pulp hemorrhage or pulp necrosis.
- •Medically compromised patients who have systemic disease.
- •Uncooperative children who refuse treatment.
Arms & Interventions
Neoputty MTA pulpotomy
Intervention: NeoPUTTY MTA pulpotomy (Procedure)
Endoflas pulpectomy
Intervention: Endoflas pulpectomy (Procedure)
Outcomes
Primary Outcomes
postoperative pain
Time Frame: within 24 hours, after 1 week, 3, 6, 9, and 12 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Manar Motawie Abdulfattah
DR.
Cairo University