Molar Incisor HypomineralisationNCT07494682
Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities
A study testing Resin infiltration and Etch Bleach Seal Technique in people with Molar Incisor Hypomineralisation and Enamel Hypomineralization, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralisation, Enamel Hypomineralization, Tooth Discoloration
- What is being tested?
- Resin infiltration and Etch Bleach Seal Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 May 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Dentistry , Denizli
Denizli, 20160
About this study
Official title: Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities: Effects on Esthetic Perceptions of Children and Their Parents
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.
Read the 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.
- Being tested
- Resin infiltration, Etch Bleach Seal Technique
- Keywords
- Molar incisor hypomineralization, Resin infiltration technique, Etch bleach seal technique, Minimally invasive treatment, Esthetic perception
- Medical subject headings
- Molar Hypomineralization, Dental Enamel Hypomineralization, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationOther
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 TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Etch Bleach Seal Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
Secondary outcomes (1)
Color change of MIH-related anterior enamel opacities
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.
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 May 2024
- Primary completion24 Sep 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Bolaca, Pamukkale University
- Investigators
- Arif Bolaca, Dr, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494682
- Sponsor's protocol ID
- 2024DİŞF001
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations, as the study involves pediatric participants. Data are available from the corresponding author on reasonable request and with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Minimally Invasive Approaches for Masking Molar-Incisor Hypomineralization Opacities: Effects on Esthetic Perceptions of Children and Their Parents
- ClinicalTrials.gov ID
- NCT07494682
- Acronym / sponsor ID
- 2024DİŞF001
- Keywords
- Molar incisor hypomineralization, Resin infiltration technique, Etch bleach seal technique, Minimally invasive treatment, Esthetic perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Experimental | Other: Resin infiltrationParticipants 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. |
| Etch Bleach Seal Technique | Experimental | Other: Etch Bleach Seal TechniqueParticipants 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. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resin infiltrationA 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. | Other | Resin infiltration |
| Etch Bleach Seal TechniqueA 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. | Other | Etch Bleach Seal Technique |
Primary outcome
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.
1 secondary outcome
Color change of MIH-related anterior enamel opacities
Time frame: Baseline, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations, as the study involves pediatric participants. Data are available from the corresponding author on reasonable request and with appropriate ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arif Bolaca, Dr study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and Etch Bleach Seal Technique in people with Molar Incisor Hypomineralisation and Enamel Hypomineralization, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in esthetic perception of children and parents (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.