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Clinical Trials in Egypt / NCT07850986
Active, not recruiting Not applicable

Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization

NCT07850986 · tracked via the Priya Life Science Egypt tracker
Sponsor
Alaa Khafagy
Phase
Not applicable
Started
2026-05-01
Last updated
2026-10-01

Condition(s) studied

Molar Incisor HypomineralisationIrreversible PulpitisImmature Molars

Investigational drug(s) / intervention(s)

pulpotomy for MIH affected immature PFMspartial pulpotomy for MIH affected immature PFMspulpotomy for non-MIH affected immature PFMspartial pulpotomy for non-MIH affected immature PFMs

pulpotomy for MIH affected immature PFMs: Step-by-step pulpotomy procedure for MIH affected immature PFMs

partial pulpotomy for MIH affected immature PFMs: Step-by-step partial pulpotomy procedure for MIH affected immature PFMs

pulpotomy for non-MIH affected immature PFMs: Step-by-step pulpotomy procedure for non-MIH affected immature PFMs

partial pulpotomy for non-MIH affected immature PFMs: Step-by-step partial pulpotomy procedure for non-MIH affected immature PFMs

Study summary

This randomized controlled clinical trial aims to evaluate and compare pain levels associated with partial pulpotomy (PP) and full pulpotomy (FP) in immature permanent first molars diagnosed with irreversible pulpitis. The study specifically investigates differences between molars affected by molar incisor hypomineralization (MIH) and those without MIH.

A total of 132 children aged 6-8 years will be randomly allocated into four groups based on MIH status and type of pulpotomy. All participants will receive pre-emptive ibuprofen prior to treatment. Pain will be assessed preoperatively, intraoperatively, and postoperatively using validated scales.

The study aims to evaluate pre-, intra-, and postoperative pain levels after partial pulpotomy (PP) and full pulpotomy (FP) in MIH-affected immature permanent first molars (PFMs) with irreversible pulpitis.

Eligibility

Sex
ALL
Min age
6 Years
Max age
8 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Age ranges from 6 - 8 years. * Children free of any systemic disease or special health care need (ASA I). * Positive or definitely positive behavior during preoperative assessments * according to the Frankl Rating Scale (score 3 or 4). * Patients whose parents will give their written consent to participate. * MIH-affected PFMs with Treatment Need index (TNI) 4c). * Schiff Cold Air Sensitivity Scale (SCASS) scores 2 and 3. * Restorable MIH-affected PFMs associated with signs and symptoms of irreversible pulpitis * Spontaneous, unprovoked pain * Lingering pain after thermal stimulus. * Exacerbation by postural changes. * Referred pain. * Nocturnal pain. * Haemostasis achieved within 10 minutes * Negative response to percussion and palpation * Restorable non-MIH-affected PFMs associated with signs and symptoms of irreversible pulpitis. Exclusion Criteria: * Medically compromised patients. * Allergies to local anesthesia. * Intolerance to NSAIDs. * Patients with Frankl scores 1 and 2. * Patients who took analgesics or antibiotics in the last 12 hours. * Non-restorable permanent first molars. * Non-vital permanent first molars (negative response to pulp testing). * Tooth mobility with grades 2 and 3. * pocket depth greater than 5 mm. * Radiographic evidence of vertical root fracture, perforation, and/or peri-apical radiolucency. * Widening of periodontal ligament. * Pain on percussion. * Uncontrolled puplpal haemorrhage lasting more than 10 minutes * Degenerating pulp

Primary outcome measure(s)

  • pain evaluation — one week
    To evaluate pre-, intra-, and postoperative pain levels after partial pulpotomy (PP) and full pulpotomy (FP) in MIH-affected immature permanent first molars (PFMs) with irreversible pulpitis using Wong-Baker's pain rating scale. minimum value=0 better outcome maximum value=10 worse outcome

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry, Alexandria University Alexandria Alexandria Governorate

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Clinical and Radiographic Evaluation of Calcium Hypochlorite Versus Saline As Root Canal Irrigants in Pulpectomy of Primary Molars: a Randomized Clinical Trial Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07850986 on ClinicalTrials.gov ↗ ← All trials in Egypt