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 range6 Years – 14 Years

SexALL

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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…

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