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

Official title

Clinical and Radiographic Evaluation of Pulpotomy Versus Pulpectomy in Primary Molars With Irreversible Pulpitis or Necrotic Pulp: A Split-Mouth Randomized Clinical Trial

Overview

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.

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

Primary outcome measures

• Clinical and radiographic success rates of pulpotomy versus pulpectomy in primary molars of children with irreversible pulpitis or necrotic pulp over a 12-month follow-up period [Time frame: 3 months, 6 months, 9 months, and 12 months follow up post-treatment.]

Secondary outcome measures (3)

• Anxiety Level using RMS Pictorial Scale [Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).]
• Pulse Rate in beats per minute (bpm) using Pulse Oximeter [Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the procedure).]
• Oxygen Saturation (SpO₂) in percentage (%) using Pulse Oximeter [Time frame: Baseline (in the waiting area before entering the operatory), Pre-operative (immediately before the start of the procedure), Operative (during the dental treatment), and Post-operative (immediately after completion of the 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07230717 · D-S-H-22-Jun

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗