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Completed

NCT Number: NCT04685889

Resin Infiltration Treatment for MIH

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.

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Key information

Conditions

Molar Incisor Hypomineralization Anterior Teeth Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Dental Enamel Hypoplasia Developmental Defects of Enamel Enamel Caries Enamel Hypoplasia Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpaşa University

Tokat Province, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resin infiltration

Procedure

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.

Primary outcomes

  1. Changes in the Mineralisation degree

    Time frame: 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)

  2. Changes in the lesion colour

    Time frame: 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)

  3. Lesion size evaluated using cross polarization technique

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Dec 28, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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