Active — Not RecruitingNot Applicable

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

Turkey (Türkiye)55 participantsStarted 2025-12-01

Plain-language 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. 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.

Who can participate

Age range

6 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 par…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Lesion Color and Clinical Appearance

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

Trial details

NCT IDNCT07469124

SponsorInonu University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Molar Incisor Hypomineralization trials