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Molar Incisor HypomineralizationNCT07469124

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

A study testing Resin Infiltration, Microabrasion Followed by Resin Infiltration and Air Abrasion Followed by Resin Infiltration in people with Molar Incisor Hypomineralization, run by Inonu University at 1 site in Turkey (Türkiye).

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

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. Read more about this study

Who is it for?
Ages 6 to 14 years
Conditions the study is for
Molar Incisor Hypomineralization
What is being tested?
Resin Infiltration, Microabrasion Followed by Resin Infiltration and Air Abrasion Followed by Resin Infiltration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 15 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • İnönü University Faculty of Dentistry

    Malatya, Battalgazi, 44320

Other trials in Turkey (Türkiye)

About this study

Official title: 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?
Read more

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.

Read the 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.

Being tested
Resin Infiltration, Microabrasion Followed by Resin Infiltration, Air Abrasion Followed by Resin Infiltration
Keywords
Resin Infiltration, Molar Incisor hypomineralization, Pediatric Dentistry, Enamel Defects, Dental Hypersensitivity, Minimally Invasive Treatment, Clinical Follow-Up, Oral Health Related Quality of Life, Enamel Microabrasion, Air abrasion, Combined Treatment
Medical subject headings
Molar Hypomineralization

What participants receive

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

  • Resin InfiltrationProcedure or surgery

    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.

  • Microabrasion Followed by Resin InfiltrationProcedure or surgery

    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.

  • Air Abrasion Followed by Resin InfiltrationProcedure or surgery

    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.

Study groups in NCT07469124
Study groupRoleWhat they receive
Creamy/white colored lesions - Resin InfıltrationExperimentalNot described
Receives: Procedure: Resin Infiltration
Creamy/white colored lesions - Microabrasion+Resin InfıltrationExperimentalNot described
Receives: Procedure: Microabrasion Followed by Resin Infiltration
Creamy/white colored lesions - Air abrasion+Resin InfıltrationExperimentalNot described
Receives: Procedure: Air Abrasion Followed by Resin Infiltration
Yellow/brown colored lesions - Resin InfiltrationExperimentalNot described
Receives: Procedure: Resin Infiltration
Yellow/brown colored lesions - Microabrasion+Resin InfiltrationExperimentalNot described
Receives: Procedure: Microabrasion Followed by Resin Infiltration
Yellow/brown colored lesions - Air abrasion+Resin InfiltrationExperimentalNot described
Receives: Procedure: Air Abrasion Followed by Resin Infiltration

What is being measured

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

  1. Change in Lesion Color and Clinical Appearance

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months

Secondary outcomes (4)
  1. Change in Tooth Sensitivity (Visual Analog Scale)

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months

  2. Change in Tooth Sensitivity (Schiff Cold Air Sensitivity Scale)

    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.

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

  3. Change in Oral Health-Related Quality of Life (COHIP-SF-19)

    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.

    Measured: Baseline, 3 months and 6 months

  4. Change in Oral Health-Related Quality of Life (Parental-Caregiver Perceptions Questionnaire)

    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.

    Measured: Baseline, 3 months, and 6 months

Timeline

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

  1. First posted13 Mar 2026
  2. Study start1 Dec 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

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
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07469124
Sponsor's protocol ID
BAP-4123
Status last verified
Feb 2026
First submitted
3 Mar 2026
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hoan NQ, Huyen NP, Son DC, Thien DH, Sabet CJ, Ngoc VTN. Effectiveness of resin infiltration in the management of anterior teeth affected by molar incisor hypomineralisation (MIH): A systematic review and meta-analysis. J Dent. 2024 Oct;149:105254. doi: 10.1016/j.jdent.2024.105254. Epub 2024 Jul 26.

    PubMed 39067648
  • Jawdekar AM, Kamath S, Kale S, Mistry L. Assessment of oral health-related quality of life (OHRQoL) in children with molar incisor hypomineralization (MIH) - A systematic review and meta-analysis of observational studies. J Indian Soc Pedod Prev Dent. 2022 Oct-Dec;40(4):368-376. doi: 10.4103/jisppd.jisppd_27_23.

    PubMed 36861552
  • Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13.

    PubMed 38744567
  • Hasmun N, Vettore MV, Lawson JA, Elcock C, Zaitoun H, Rodd HD. Determinants of children's oral health-related quality of life following aesthetic treatment of enamel opacities. J Dent. 2020 Jul;98:103372. doi: 10.1016/j.jdent.2020.103372. Epub 2020 May 11.

    PubMed 32437856

Questions about this trial

What is this clinical trial studying?

A study testing Resin Infiltration, Microabrasion Followed by Resin Infiltration and Air Abrasion Followed by Resin Infiltration in people with Molar Incisor Hypomineralization, run by Inonu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Lesion Color and Clinical Appearance (time frame: Baseline, 1 month, 3 months, 6 months, 9 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469124, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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