Resin Infiltration Treatment for MIH

Study Overview
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Brief Summary
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The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

Detailed Description
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A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control). Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure. Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure. Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

Official Title
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Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces

Conditions
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Molar Incisor Hypomineralization, Enamel Hypoplasia, Enamel Caries, Anterior Teeth

Intervention / Treatment
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* Procedure: Resin infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH. Exclusion Criteria: Dental caries and filling on anterior teeth. Dental anomaly on anterior teeth. Undergoing orthodontic treatment. Periodontal diseases. Cognitive and behavioural problems.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Icon Group<br>Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure. | Procedure: Resin infiltration<br>* A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated. Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device.<br>|
| No Intervention: Control Group<br>No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Mineralisation degree | MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence) | Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later | 
| Changes in the lesion colour | Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths) | Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later | 
| Lesion size evaluated using cross polarization technique | Changes in the MIH lesions size was evaluated using cross polarization technique | Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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molar incisor hypomineralisation, resin infiltration, discoloration, enamel, lesion