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Completed

NCT Number: NCT07715370

Three Approaches of Resin Infiltration for MIH Incisor Opacities

Molar incisor hypomineralization (MIH) is a condition which involves enamel hypomineralization of one to four first permanent molars with or without permanent incisors. Affected permanent incisors present with demarcated enamel opacities which cause esthetic and psychological problems to patients with MIH. Microabrasion and etch-bleach surface treatment can provide easier, conservative, and biologically driven treatment approach compared to macroabrasion prior to prolonged resin infiltration for treating enamel opacities in incisors of MIH patients.

The aim of this study is to evaluate the effect of microabrasion and etch-bleach surface treatment compared to macroabrasion prior to prolonged resin infiltration on esthetic appearance of permanent incisors affected with demarcated enamel opacities in MIH patients.

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Key information

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, Cairo Governorate, Egypt

About this study

In this randomized controlled trial, patients aged 8-14 years suffering from demarcated enamel opacities in permanent incisors of MIH patients will be randomly divided into three groups according to surface treatment.

The first group will receive microabrasion, the second group will receive microabrasion and etch-bleach surface treatments while the third group will receive macroabrasion surface treatment. Resin infiltration will be then applied to all groups with prolonged infiltration time for 30 minutes.

Color changes will be assessed using Vita easy shade whereas oral health related quality of life will be assessed using Child Oral-Health-Related Quality of Life Questionnaire. Assessment will be done before, immediately after; and 1, 3, 6 and 12 months after treatment protocol in all groups.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cooperative healthy male and female children aged 8 to 14 years.
  • MIH diagnosed patients according to the criteria of European Academy of Pediatric Dentistry (EAPD) with demarcated enamel opacity that caused esthetic discomfort to them and their guardian, involving at least one maxillary or mandibular permanent incisor.
  • At least one-third of the affected tooth crown should be visible in the oral cavity.

Exclusion criteria

  • Children with behavioral, cognitive, physical, or medical conditions that will affect or complicate the treatment.
  • Other developmental defects of dental enamel rather than MIH (i.e. dental fluorosis, enamel hypoplasia, amelogenesis imperfecta or Turner's tooth)
  • Loss of tooth structure due to post-eruptive enamel breakdown or caries.
  • Periodontal disease of the affected tooth.
  • Incisors previously subjected to trauma that might lead to loss of tooth structure or compromise the pulp vitality.
  • Previous preventive, restorative or orthodontic treatment on the affected tooth.

Treatment and study plan

Resin infiltration

Procedure

Etching using 15% hydrochloric acid for 2 minutes, followed by rinsing for 30 seconds then air dryness.

Drying using 99% ethanol for 30 seconds. Resin infiltration for 30 minutes, then light curing for 40 seconds.

microabrasion

Procedure

Microabrasive paste will be applied to the teeth for 60 seconds using low-speed bristle cups. This procedure will be repeated ten times with rinsing and dryness after each cycle.

Etch-bleach

Procedure

Etching of enamel using 37% phosphoric acid for 60 seconds. After rinsing, 5% NaOCl will be applied to the etched enamel surface for 10 minute.

Macroabrasion

Procedure

A mild preparation of enamel using a high-speed diamond finishing stone with copious water spray.

Primary outcomes

  1. Color Change

    Time frame: Preoperatively - Immediately postoperatively - 1, 3, 6 12 months postoperatively

    Evaluating color change of the demarcated enamel opacity in permanent incisors of MIH patients using Vita easy shade.

Secondary outcomes

  1. Oral health related quality of life

    Time frame: Preoperatively - Immediately Postoperatively - 1, 3, 6, 12 months postoperatively

    Evaluating oral health related quality of life (OHRQoL) using Child Oral-Health-Related Quality of Life Questionnaire.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Evaluation of Three Different Approaches Using Prolonged Resin Infiltration on Demarcated Enamel Opacities in Incisors Affected With Molar Incisor Hypomineralization: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 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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