- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07494682
Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities
Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities: Effects on Esthetic Perceptions of Children and Their Parents
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Denizli, Turkey (Türkiye), 20160
- Pamukkale University Faculty of Dentistry , Denizli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Resin infiltration
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.
|
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.
|
|
Experimental: Etch Bleach Seal Technique
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 1 month, 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Arif Bolaca, Dr, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024DİŞF001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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