Resin Infiltration Treatment for MIH

Not Applicable

Completed

• Conditions: Anterior Teeth; Enamel Hypoplasia; Enamel Caries; Molar Incisor Hypomineralization
• Interventions: Procedure: Resin infiltration

• Registration Number: NCT04685889
• Lead Sponsor: Tokat Gaziosmanpasa University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-23
• Primary Completion: 2018-06-23
• Study Completion: 2019-12-20
• Status Verified: 2020-12
• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-24
• Last Update Submitted: 2020-12-24
• Study First Posted: 2020-12-28
• Last Update Posted: 2020-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icon Group	Resin infiltration	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Gaziosmanpaşa University; 🇹🇷 Tokat, Turkey