Clinical Evaluation of Resin Infiltration Treatment of MIH-affected Teeth in Pediatric Patients

March 9, 2026 updated by: Zekiye Seyma Gümüşboğa, Inonu University

Evaluation of the Clinical Success of Different Pretreatments in the Resin Infiltration Treatment of Permanent Incisors Affected by Molar Incisor Hypomineralization in Pediatric Patients and the Effect of the Treatment on Quality of Life

The goal of this clinical trial is to examine the clinical success of different pre-treatments in resin infiltration therapy applied to the incisors of pediatric patients with Molar Incisor Hypomineralization (MIH) and to evaluate the impact of treatment on the quality of life of children. The main questions that this study aims to answer are:

  • Does resin infiltration therapy improve the color and surface appearance of incisors affected by MIH?
  • Is there a reduction in tooth sensitivity after treatment?
  • Are patients and their parents satisfied with the treatment results?
  • Is there an improvement in the quality of life of children after treatment?

Researchers will apply resin infiltration therapy to incisors affected by MIH and evaluate the results over a 12-month follow-up period. Participants will:

  • Receive resin infiltration therapy on their MIH incisors.
  • Attend follow-up appointments at 1, 3, 6, 9, and 12 months.
  • At the follow-up appointments, the teeth will be evaluated with clinical examination and photographs.
  • Participants will complete questionnaires regarding tooth sensitivity and quality of life related to oral health.

The results of this study are expected to contribute to the development of minimally invasive treatment options for children with MIH.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Children aged 6-14 years with molar incisor hypomineralization (MIH) will be evaluated for the presence of opaque lesions in their permanent incisors. Children with opaque lesions will be divided into two groups based on the classification published by Ghanim et al. in 2015: those with opaque areas limited to creamy-white to yellow-brown color. Teeth showing other developmental enamel defects (fluorosis, enamel hypoplasia, amelogenesis imperfecta, dental caries, etc.) will be excluded. The teeth in each of the two groups will be further subdivided into three subgroups, and treatments will be performed using Icon® (DMG, Hamburg, Germany) for resin infiltration, Opalustre (Ultradent Products, Cologne, Germany) for microabrasion, and Coxo CA-1 (Foshan Coxo Medical Instrument Co., Ltd., China) for air abrasion, either individually or in combination. The groups and procedures to be applied are planned as follows:

Group 1: Creamy-White opaque area, Icon Group 2: Creamy-White opaque area, Opalustre + Icon Group 3: Creamy-White opaque area, Coxo CA-1 + Icon Group 4: Yellow-Brown opaque area, Icon Group 5: Yellow-Brown opaque area, Opalustre + Icon Group 6: Yellow-Brown opaque area, Coxo CA-1 + Icon Informed consent forms will be signed by patients and their parents who wish to participate in the study.

The color stability and sensitivity of the opaque lesions after treatment will be checked at 1, 3, 6, 9, and 12 months. Standard photographs will be taken with a DSLR camera before treatment and at all control appointments.

A spectrophotometer will be used to evaluate color stability. The Schiff Cold Air Sensitivity Test (SCASS) and Visual Analog Scale (VAS) will be used to assess sensitivity. The validated COHIP-SF-19 questionnaire will be administered to children before treatment and 3-6 months after treatment to assess their quality of life. Parents will also be administered the P-CPQ questionnaire to assess their child's oral health and quality of life.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Battalgazi
      • Malatya, Battalgazi, Turkey (Türkiye), 44320
        • Inonu University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The child must be between 6 and 14 years old,
  • Diagnosed with molar incisor hypomineralization (according to EAPD criteria) and have lesions in the incisors,
  • The tooth to be treated must not be cavitated or must not require restoration,
  • Having the reading and writing skills to answer the scale,
  • Having no communication impairments (auditory, visual, cognitive),
  • Having no systemic illnesses that would affect oral health,
  • Not taking any medications that would affect oral health,
  • Both the child and their parents must be willing to complete the scale,
  • Agree to attend the 12-month follow-up appointments.

Exclusion Criteria:

  • Presence of enamel defects other than MIH in the target tooth, such as dental fluorosis, amelogenesis imperfecta, or enamel hypoplasia;
  • Presence of significant caries, extensive dentin caries, large restorations, fissure sealants, composite restorations, or any existing restoration that may interfere with lesion evaluation in the affected tooth;
  • Presence of spontaneous pain, abscess/fistula, suspected pulpitis, or need for endodontic treatment in the affected tooth;
  • Presence of orthodontic appliances (e.g., brackets or bands) on the tooth to be evaluated that may interfere with color measurement;
  • Known allergy or hypersensitivity to the dental materials used in the study;
  • History of recent microabrasion, bleaching, resin infiltration, or similar procedures performed on the affected tooth;
  • Inability of the participant to read and write sufficiently to complete the questionnaire;
  • Presence of any systemic disease that may affect oral health;
  • Use of medications that may affect oral health;
  • Presence of any communication barriers (hearing, visual, or cognitive impairment) that may interfere with study participation;
  • Refusal or unwillingness of either the participant or the parent/guardian to complete the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Creamy/white colored lesions - Resin Infıltration
Procedure: Resin Infiltration
A minimally invasive treatment in which a low-viscosity resin material is applied to porous enamel lesions to reduce opacity, improve clinical appearance, and stabilize the enamel surface.
Experimental: Creamy/white colored lesions - Microabrasion+Resin Infıltration
Procedure: Microabrasion Followed by Resin Infiltration
A combined treatment protocol involving enamel microabrasion prior to resin infiltration to evaluate its effect on treatment efficacy, lesion appearance, and clinical outcomes in hypomineralized enamel lesions.
Experimental: Creamy/white colored lesions - Air abrasion+Resin Infıltration
Procedure: Air Abrasion Followed by Resin Infiltration
A combined minimally invasive treatment in which air abrasion is used for enamel surface preparation prior to resin infiltration to optimize resin penetration and improve esthetic and clinical outcomes in hypomineralized lesions.
Experimental: Yellow/brown colored lesions - Resin Infiltration
Procedure: Resin Infiltration
A minimally invasive treatment in which a low-viscosity resin material is applied to porous enamel lesions to reduce opacity, improve clinical appearance, and stabilize the enamel surface.
Experimental: Yellow/brown colored lesions - Microabrasion+Resin Infiltration
Procedure: Microabrasion Followed by Resin Infiltration
A combined treatment protocol involving enamel microabrasion prior to resin infiltration to evaluate its effect on treatment efficacy, lesion appearance, and clinical outcomes in hypomineralized enamel lesions.
Experimental: Yellow/brown colored lesions - Air abrasion+Resin Infiltration
Procedure: Air Abrasion Followed by Resin Infiltration
A combined minimally invasive treatment in which air abrasion is used for enamel surface preparation prior to resin infiltration to optimize resin penetration and improve esthetic and clinical outcomes in hypomineralized lesions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lesion Color and Clinical Appearance
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months
Color change of hypomineralized enamel lesions will be objectively evaluated using a dental spectrophotometer. Color differences between baseline and follow-up measurements will be recorded to assess treatment effectiveness.
Baseline, 1 month, 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tooth Sensitivity (Visual Analog Scale)
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months
Tooth sensitivity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). A standardized air stimulus will be applied to the tooth by the dentist, and the participant will rate the perceived sensitivity using the VAS scale. Higher scores indicate greater tooth sensitivity. Changes in sensitivity scores will be evaluated by comparing baseline and follow-up measurements.
Baseline, 1 month, 3 months, 6 months, 9 months and 12 months
Change in Tooth Sensitivity (Schiff Cold Air Sensitivity Scale)
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Tooth sensitivity will be assessed by a trained dentist using the Schiff Cold Air Sensitivity Scale (SCASS) following standardized air stimulus application. The scale ranges from 0 to 3, where higher scores indicate greater tooth sensitivity. Changes in sensitivity scores will be evaluated by comparing baseline and follow-up measurements.
Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months
Change in Oral Health-Related Quality of Life (COHIP-SF-19)
Time Frame: Baseline, 3 months and 6 months
Children will complete the Child Oral Health Impact Profile Short Form (COHIP-SF-19) questionnaire to assess oral health-related quality of life. Total scores range from 0 to 76, with higher scores indicating better oral health-related quality of life. Changes in quality-of-life scores will be evaluated by comparing baseline and follow-up assessments.
Baseline, 3 months and 6 months
Change in Oral Health-Related Quality of Life (Parental-Caregiver Perceptions Questionnaire)
Time Frame: Baseline, 3 months, and 6 months
Parents will complete the Parental-Caregiver Perceptions Questionnaire (P-CPQ) to evaluate their child's oral health-related quality of life. The total score ranges from 0 to 124, with higher scores indicating poorer oral health-related quality of life. Changes in quality-of-life scores will be evaluated by comparing baseline and follow-up assessments.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Zekiye Şeyma Gümüşboğa, Assistant Professor, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAP-4123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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