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Completed

NCT Number: NCT07494682

Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities

This clinical study aimed to compare the effectiveness of two minimally invasive approaches for masking molar-incisor hypomineralization (MIH) opacities and to evaluate esthetic perceptions of children and their parents. Participants with MIH-affected incisors received either resin infiltration or etch-bleach-seal treatment. Esthetic outcomes and satisfaction levels were assessed using standardized scales.

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Key information

About this study

Molar-incisor hypomineralization (MIH) is a qualitative enamel defect that often leads to esthetic concerns, particularly in anterior teeth. Minimally invasive treatment approaches such as resin infiltration and etch-bleach-seal techniques have been proposed to improve the appearance of MIH opacities.

This study aimed to compare the effectiveness of these two approaches in masking MIH opacities in permanent incisors and to evaluate esthetic perceptions from both children and their parents. Esthetic perceptions related to dental appearance were evaluated using the ''Child's and Parent's Questionnaire about Teeth Appearance''. The color masking effectiveness of resin infiltration and the etch-bleach-seal (EBS) technique on MIH-related anterior enamel opacities were evaluated using a spectrophotometer (VITA Easyshade® V, Sackingen, Germany).

The findings are expected to contribute to evidence-based decision-making for minimally invasive esthetic management of MIH.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 8 and 10 years,
  • Diagnosis of MIH according to the European Academy of Paediatric Dentistry (EAPD) criteria [19], with at least one permanent incisor exhibiting well-demarcated white-cream and/or yellow-brown enamel opacities causing esthetic concern to the child and/or parents,
  • Absence of urgent dental treatment needs, with completed treatment of posterior teeth,
  • Ability of both children and parents to read and understand Turkish.

Exclusion criteria

  • Presence of urgent dental treatment or requirement for restorative treatment of MIH affected permanent first molars during the study period,
  • Presence of dental or facial anomalies other than MIH (e.g. hypodontia, cleft lip and/or palate),
  • Presence of dental caries, crown fractures, or extrinsic/intrinsic tooth discolorations that could compromise esthetic perception,
  • Presence of other developmental enamel defects (e.g. enamel hypoplasia, amelogenesis imperfecta, fluorosis, or hypoplasia related to previous dental trauma),
  • Previous restorative treatment, resin infiltration, microabrasion, and/or tooth whitening on the affected incisors,
  • Children and/or parents who were unlikely to attend follow-up visits or were unable to read and understand Turkish.

Treatment and study plan

resin infiltration

Other

A minimally invasive dental procedure used to mask enamel opacities associated with molar incisor hypomineralization. The technique involves etching the enamel surface, drying with ethanol, and applying a low-viscosity resin infiltrant (Icon®, DMG), followed by light curing and polishing in a single clinical session.

Etch Bleach Seal Technique

Other

A minimally invasive dental procedure used to improve the appearance of enamel opacities associated with molar incisor hypomineralization. The technique includes phosphoric acid etching, application of sodium hypochlorite for bleaching, and sealing with a resin-based sealant, followed by light curing and polishing in a single clinical session.

Primary outcomes

  1. Change in esthetic perception of children and parents

    Time frame: Baseline and 3 months

    Esthetic perception was assessed using the Child's and Parent's Questionnaire about Teeth Appearance. Changes in physical, psychological, and social domains, as well as satisfaction with tooth appearance, were evaluated before treatment and at 3-month follow-up.

Secondary outcomes

  1. Color change of MIH-related anterior enamel opacities

    Time frame: Baseline, 1 month, 3 months

    Color changes were measured using a spectrophotometer based on the CIELAB system. Color differences (ΔE values) were calculated to assess the effectiveness of masking enamel opacities.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities: Effects on Esthetic Perceptions of Children and Their Parents

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

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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