NCT06929247

Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years.

Clinical and Radiographic Evaluation of Pulpotomy Using Neoputty MTA Versus Pulpectomy Using Metapex in Vital Primary Molars Diagnosed With Symptomatic Irreversible Pulpitis in Children Aged 4 to 9 Years: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Mohamed Nashaat Mohamed · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

itle: Evaluation of Pulpotomy using Neoputty MTA vs. Pulpectomy using Metapex in Children (4-9 years). Objective: Compare clinical and radiographic success of pulpotomy vs. pulpectomy for vital primary molars with irreversible pulpitis. Design: Randomized controlled trial with 2-arm parallel groups. Participants: Healthy children aged 4-9 with specific inclusion/exclusion criteria. Outcomes: Primary (pain relief, absence of complications) and secondary (radiographic success).

Detailed description

Background and Rationale Treating irreversible pulpitis in primary molars is challenging due to complex root canal anatomy and rapid progression of pulp inflammation. Pulpectomy is the standard approach, but its technical difficulty often necessitates referral to specialists. New bioactive materials like Neoputty MTA and improved understanding of pulp biology justify reevaluation of less invasive treatments like pulpotomy. This study addresses the lack of clinical trials comparing pulpotomy with pulpectomy in cases of irreversible pulpitis in primary molars. Aim To compare the clinical and radiographic success of pulpotomy using Neoputty MTA vs. pulpectomy using Metapex in vital primary molars with symptomatic irreversible pulpitis in children aged 49 years. Hypothesis Null Hypothesis: No significant difference in treatment outcome between pulpotomy and pulpectomy. Methodology Participants * Setting: Pediatric Dentistry Department, Faculty of Dentistry, Cairo University * Eligibility: Healthy (ASA I/II), cooperative children aged 49 with vital primary molars exhibiting signs of irreversible pulpitis. * Exclusion: Necrotic pulp, periapical pathology, pathological mobility, poor restorability, or refusal of crown placement. Sample Size 40 teeth per group (total 80), accounting for 15% dropout. Based on expected 20% difference in outcomes and 80% power. Interventions Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration. Pulpectomy (Control Group): Complete root canal debridement and obturation with Metapex. Same restoration and crown protocol. Outcomes Primary: Post-operative pain (VAS), clinical and radiographic success over 12 months. Secondary: Pain assessment at 24 hours and 7 days post-treatment using VAS. Follow-up Timeline Evaluations at baseline, 24h, 1w, 3m, 6m, 9m, and 12m post-intervention. Randomization and Blinding Randomization via opaque sealed envelopes. Outcome assessors blinded.

Conditions

• Pulpitis - Irreversible

Interventions

Type	Name	Description
PROCEDURE	Pulpotomy using Neoputty Mineral Trioxide Aggregate	Pulpotomy (Test Group): Removal of coronal pulp followed by Neoputty MTA placement and restoration.
PROCEDURE	single visit pulpectomy using metapex	pulpectomy: removal of radicular pulp followed by metapex placement and final restoration

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2025-04-16
• Last updated: 2025-04-16