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

NCT07494682 | Completed

• 1 other identifier: 2024DİŞF001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar Incisor Hypomineralisation; Enamel Hypomineralization; Tooth Discoloration

Keywords

Molar incisor hypomineralization; Resin infiltration technique; Etch bleach seal technique; Minimally invasive treatment; Esthetic perception

Outcome Measures

Primary Outcomes (1)

• Change in esthetic perception of children and parents

  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.

  Baseline and 3 months

Secondary Outcomes (1)

• Color change of MIH-related anterior enamel opacities

  Baseline, 1 month, 3 months

Study Arms (2)

Resin infiltration

EXPERIMENTAL

Participants in this arm received resin infiltration treatment for masking molar incisor hypomineralization-related enamel opacities. The procedure involved etching with hydrochloric acid, ethanol application for dehydration, and application of a low-viscosity resin infiltrant (Icon®, DMG) followed by light curing and polishing in a single clinical session.

Other: Resin infiltration

Etch Bleach Seal Technique

EXPERIMENTAL

Participants in this arm received the etch bleach seal technique for masking molar incisor hypomineralization-related enamel opacities. The procedure included 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.

Other: Etch Bleach Seal Technique

Interventions

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.

Resin infiltration

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.

Etch Bleach Seal Technique

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Faculty of Dentistry , Denizli

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization; Dental Enamel Hypomineralization; Tooth Discoloration

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Arif Bolaca, Dr

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the clinical procedures, blinding of the operator was not possible. To minimize potential assessment bias, the evaluation of esthetic perception questionnaires completed by children and their parents were performed by another investigator who was blinded group allocation. In addition, children and their parents were not informed about the specific treatment technique applied and informed only that a minimally invasive esthetic procedure would be performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: May 6, 2024
• Primary Completion: September 24, 2024
• Study Completion: December 20, 2024
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)