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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorAjman University

About this trial

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.

Eligibility criteria

Qualifiers

Patients in healthy medical conditions

Bilateral/contralateral primary molars diagnosed with irreversible pulpitis or necrotic pulp

Periapical or bifurcation radiolucency

Chronic apical intraoral abscess

Disqualifiers

Patients who are medically compromised (with systemic conditions)

Acute extraoral abscess

Grade II or III tooth mobility

External root resorption in more than 1/3 of roots

Trial design

Treatments tested in this trial

  • Pulpotomy
  • Pulpectomy

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators