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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Pulpotomy
Procedure/SurgeryPulpotomy 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/SurgeryCalcium Hydroxide, Iodoform, Silicon oil
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: PulpotomyExperimental treatment 1 intervention
Group B: PulpectomyActive comparator 1 intervention
Trial outcomes
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
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.
Time frame
3 months, 6 months, 9 months, and 12 months follow up post-treatment.Secondary outcomes
1
Anxiety Level using RMS Pictorial Scale
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.
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).2
Pulse Rate in beats per minute (bpm) using Pulse Oximeter
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.
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).3
Oxygen Saturation (SpO₂) in percentage (%) using Pulse Oximeter
Oxygen saturation (SpO₂) will be measured in percentage (%) using a calibrated digital pulse oximeter to assess physiological changes associated with anxiety during dental treatment.
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).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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