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

NCT ID: NCT07230717

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-05-01

Brief 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.

Detailed Description

With increasing emphasis on conservative and predictable pulp therapy in pediatric dentistry, this study aims to evaluate pulpotomy using Pulpotec as a potential alternative to pulpectomy using Metapex in the management of primary molars with irreversible pulpitis or necrotic pulp.

This split-mouth randomized controlled clinical trial will include 25 children aged 4-8 years attending the Postgraduate Pediatric Dental Clinic at Ajman University, UAE. Each participant will contribute two contralateral primary molars-one assigned to the intervention group (Pulpotomy with Pulpotec) and the other to the control group (Pulpectomy with Metapex, a calcium hydroxide and iodoform paste).

The outcome will assess and compare the clinical and radiographic success rates of pulpotomy and pulpectomy procedures performed in primary molars diagnosed with irreversible pulpitis or necrotic pulp. Clinical success will be defined by the absence of pain, swelling, sinus tract, mobility, or tenderness to percussion. Radiographic success will be defined by the absence of periapical or inter-radicular radiolucency, internal or external resorption, and evidence of continued root resorption consistent with normal exfoliation. In addition, dental anxiety will be assessed using the RMS Pictorial Anxiety Scale, and physiological parameters such as pulse rate (beats/min) and oxygen saturation (SpO₂, %) will be recorded using a pulse oximeter to explore potential correlations between anxiety and treatment response.

Conditions

Pulpitis - Irreversible; Pulp Necrosis; Pulp Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulpotomy

Pulpotomy

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: PROCEDURE

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

Pulpectomy

Pulpectomy

Group Type: ACTIVE_COMPARATOR

Pulpectomy

Intervention Type: PROCEDURE

Calcium Hydroxide, Iodoform, Silicon oil

Interventions

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

Intervention Type: PROCEDURE

Pulpectomy

Calcium Hydroxide, Iodoform, Silicon oil

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients in healthy medical conditions
• Bilateral/contralateral primary molars diagnosed with irreversible pulpitis or necrotic pulp
• Periapical or bifurcation radiolucency
• Chronic apical intraoral abscess
• Sinus tract or fistula formation
• No tooth mobility or grade I mobility
• External root resorption less than or equal to 1/3rd of the roots
• Tooth should be restorable

Exclusion Criteria

• 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
• Physiological root resorption of more than 1/3 of the roots or near exfoliation
• Non-restorable teeth

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ajman University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Raghavendra Shetty

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

D-S-H-22-Jun

Identifier Type: -

Identifier Source: org_study_id