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Clinical Trials in Turkey / NCT07469124
Active, not recruiting Not applicable

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

NCT07469124 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2026-08-31

Condition(s) studied

Molar Incisor Hypomineralization

Investigational drug(s) / intervention(s)

Resin InfiltrationMicroabrasion Followed by Resin InfiltrationAir Abrasion Followed by Resin Infiltration

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.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
14 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
İnönü University Faculty of Dentistry Malatya Battalgazi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07469124 on ClinicalTrials.gov ↗ ← All trials in Turkey