Molar Incisor HypomineralisationNCT07850986

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

A study testing pulpotomy for MIH affected immature PFMs, partial pulpotomy for MIH affected immature PFMs and pulpotomy for non-MIH affected immature PFMs in people with Molar Incisor Hypomineralisation and Irreversible Pulpitis, run by Alaa Khafagy at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Molar Incisor Hypomineralisation, Irreversible Pulpitis, Immature Molars
What is being tested?: pulpotomy for MIH affected immature PFMs, partial pulpotomy for MIH affected immature PFMs and pulpotomy for non-MIH affected immature PFMs
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteEgypt
Study dates: 1 May 2026to 30 Oct 2026
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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).

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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.

Who cannot join

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.

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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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 555

Other trials in Egypt

About this study

Official title: Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization (a Randomized Controlled Clinical Trial)

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.

Read the detailed description

This study is a four-arm, parallel-group, single-blinded randomized controlled clinical trial designed to evaluate pain associated with vital pulp therapy in immature permanent first molars (PFMs) diagnosed with irreversible pulpitis.

The trial will include 132 children aged 6 to 8 years presenting with either MIH-affected or non-MIH-affected immature PFMs requiring treatment. Eligible teeth will be stratified based on the presence of molar incisor hypomineralization (MIH), then randomly assigned to receive either full pulpotomy (FP) or partial pulpotomy (PP), resulting in four study groups:

MIH + FP
MIH + PP
Non-MIH + FP
Non-MIH + PP

All participants will receive pre-emptive analgesia using ibuprofen (25 mg/kg) one hour prior to treatment to enhance pain control.

The primary outcome is pain assessment at multiple time points: preoperative, intraoperative, and postoperative (4, 6, 12, 24, and 48 hours, and 1 week). Pain will be evaluated using the Wong-Baker Faces Pain Rating Scale (subjective) and FLACC scale (objective).

Secondary outcomes include:

Patient cooperation assessed using the Frankl Behavioral Rating Scale
Patient satisfaction assessed using a 5-point Likert scale
Patient anxiety assessed objectively using pulse oximeter pre- and intraoperatively

All procedures will be performed under standardized clinical protocols using local anesthesia, rubber dam isolation, and biocompatible pulp capping materials. Final restorations will be completed using stainless steel crowns.

The study follows CONSORT guidelines and aims to provide evidence on the effectiveness of partial versus full pulpotomy in pain management, particularly in MIH-affected immature molars, where altered pulp characteristics may influence pain perception and treatment outcomes.

Conditions: Molar Incisor Hypomineralisation, Irreversible Pulpitis, Immature Molars
Being tested: pulpotomy for MIH affected immature PFMs, partial pulpotomy for MIH affected immature PFMs, pulpotomy for non-MIH affected immature PFMs, partial pulpotomy for non-MIH affected immature PFMs
Keywords: MIH-Affected Immature Molars, Irreversible Pulpitis, Pulpotomy, Partial Pulpotomy
Medical subject headings: Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07850986
Study group	Role	What they receive
Group IA (n=33)	Experimental	Step-by-step pulpotomy procedure for MIH affected immature PFMs Receives: Procedure: pulpotomy for MIH affected immature PFMs
Group IB (n=33)	Experimental	Step-by-step partial pulpotomy procedure for MIH affected immature PFMs Receives: 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 Receives: 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 Receives: Procedure: partial pulpotomy for non-MIH affected immature PFMs

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: one week

Secondary outcomes (4)

pain comparison
To compare pain levels (pre-, intra-, and postoperative) between PP and FP in MIH-affected and non-MIH-affected immature PFMs with irreversible pulpitis using Wong-Baker's pain rating scale.
minimum=0 better outcome maximum=10 worse outcome
Measured: one week
patient satisfaction
To compare patient satisfaction after PP and FP in MIH-affected and non-MIH-affected immature PFMs with irreversible pulpitis using 5-point likert scale.
minimum (very dissatisfied) =0 maximum (very satisfied) =5
Measured: after 1 week
patient cooperation
To compare patient cooperation during PP and FP in MIH-affected and non-MIH-affected immature PFMs with irreversible pulpitis using Frankl scale.
minimum (definitely negative) (rating score 1) maximum (definitely positive) (rating scale 4)
Measured: 1 day
Patient anxiety
Evaluate physiological stress and anxiety preoperatively and intraoperatively objectively by recording heart rate using a pulse oximeter
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202630 Oct 2026

First posted1 Oct 2026
Study start1 May 2026
Primary completion30 Oct 2026 (estimated)
Study completion30 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07850986
Sponsor's protocol ID: 1225-01/2026
Status last verified: Sep 2026
First submitted: 20 Sep 2026
Last updated: 1 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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