NCT07469124

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Inonu University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Molar Incisor Hypomineralization

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-01-31
• Completion: 2027-02-15
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Turkey (Türkiye)