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

Not Applicable

Not yet recruiting

• Conditions: Pulpitis - Irreversible

• Registration Number: NCT06922578
• Lead Sponsor: Cairo University

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Study Start: 2025-05-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative pain	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.