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

NCT07850986 | Active Not Recruiting DMC

• 1 other identifier: 1225-01/2026
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immature Molars; Molar Incisor Hypomineralisation; Irreversible Pulpitis

Keywords

MIH-Affected Immature Molars; Irreversible Pulpitis; Pulpotomy; Partial Pulpotomy

Outcome Measures

Primary Outcomes (1)

• pain evaluation

  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

  one week

Secondary Outcomes (4)

• pain comparison

  one week

• patient satisfaction

  after 1 week

• patient cooperation

  1 day

• Patient anxiety

  1 day

Study Arms (4)

Group IA (n=33)

EXPERIMENTAL

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

Procedure: pulpotomy for MIH affected immature PFMs

Group IB (n=33)

EXPERIMENTAL

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

Procedure: partial pulpotomy for MIH affected immature PFMs

Group IIA (n=33)

ACTIVE COMPARATOR

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

Procedure: pulpotomy for non-MIH affected immature PFMs

Group IIB (n=33)

ACTIVE COMPARATOR

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

Procedure: partial pulpotomy for non-MIH affected immature PFMs

Interventions

pulpotomy for MIH affected immature PFMs PROCEDURE

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

Group IA (n=33)

partial pulpotomy for MIH affected immature PFMs PROCEDURE

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

Group IB (n=33)

pulpotomy for non-MIH affected immature PFMs PROCEDURE

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

Group IIA (n=33)

partial pulpotomy for non-MIH affected immature PFMs PROCEDURE

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

Group IIB (n=33)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alaa Khafagy: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 555, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dentist ,Ministry of health and population, Egypt; Mster's candidate in pediatric dentistry, Alexandria University

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: October 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)