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NCT Number: NCT07230717

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

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.

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Key information

Conditions

Pulp Therapy Dental Pulp Diseases Dental Pulp Necrosis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulp Necrosis Pulpitis - Irreversible Stomatognathic Diseases Tooth Diseases

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulpotomy

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

Procedure

Calcium Hydroxide, Iodoform, Silicon oil

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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).

    Anxiety will be assessed using the Raghavendra Madhuri Sujata (RMS) Pictorial Scale, a validated visual scale designed to measure dental anxiety in children. Scores range from 1 to 5, where a higher score indicates a greater level of anxiety.

  2. 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).

    Pulse rate will be measured in beats per minute (bpm) using a calibrated digital pulse oximeter to assess the physiological response to anxiety during dental treatment.

  3. 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).

    Oxygen saturation (SpO₂) will be measured in percentage (%) using a calibrated digital pulse oximeter to assess physiological changes associated with anxiety during dental treatment.

Sponsors and collaborators

Lead sponsor

Ajman University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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