MedTrace Logo

Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp

NCT07230717 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-17

No results posted yet for this study

Summary

Preserving primary teeth until their normal exfoliation time is crucial for maintaining the child's normal function, esthetics, arch integrity, and correct eruption of permanent successors. Given the growing interest in conservative procedures and the clinical need for simpler, more predictable pulp therapy outcomes in children, evaluating pulpotomy with Pulpotec as a potential alternative to pulpectomy is essential.

The aim of this study is to evaluate the clinical and radiographic success of pulpotomy using Pulpotec versus pulpectomy using Metapex, a calcium hydroxide with iodoform paste, to treat primary molars in children diagnosed with irreversible pulpitis or necrotic pulp in the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. A total of 25 contralateral paired molar samples from children aged 4 to 8 will be included in this split-mouth randomized controlled study. Each child will serve as their own control, with one tooth randomized to the intervention group (Pulpotomy using Pulpotec) and the other to the control group (Pulpectomy using Metapex) to assess patients' clinical and radiographic outcomes over a 12-month follow-up period. Patients will have their dental anxiety psychometrically assessed using the RMS pictorial scale. In addition, a pulse oximeter will be used as a biological marker in the study to measure oxygen saturation and pulse rate.

Conditions

  • Pulp Therapy
  • Pulpitis - Irreversible
  • Pulp Necrosis

Interventions

PROCEDURE

Pulpotomy

Pulpotomy with pulpotec Powder: (iodoform, polyoxymethylene, excipient) and a Liquid: (dexamethasone acetate, formaldehyde, phenol, guaiacol, excipient) mixed into a paste consistency as per manufacturer instruction. Pulpectomy with metapex Content: Calcium Hydroxide, Iodoform, Silicon oil

PROCEDURE

Pulpectomy

Calcium Hydroxide, Iodoform, Silicon oil

Sponsors & Collaborators

  • Ajman University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-12-30
Completion
2027-05-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230717 on ClinicalTrials.gov