Molar Incisor HypomineralizationNCT07715370
Three Approaches of Resin Infiltration for MIH Incisor Opacities
A study testing Resin infiltration, microabrasion and Etch-bleach in people with Molar Incisor Hypomineralization, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Resin infiltration, microabrasion and Etch-bleach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jul 2026
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Resin infiltration, microabrasion, Etch-bleach, Macroabrasion
- Keywords
- Resin Infiltration, Prolonged Resin Infiltration, Microabrasion, Macroabrasion, Etch-Bleach Technique, Esthetic Improvement, Demarcated Enamel Opacities
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationProcedure or surgery
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.
microabrasionProcedure or surgery
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-bleachProcedure or surgery
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.
MacroabrasionProcedure or surgery
A mild preparation of enamel using a high-speed diamond finishing stone with copious water spray.
| Study group | Role | What they receive |
|---|---|---|
| Microabrasion | Experimental | Microabrasion to the teeth will be done first, followed by ICON etch, ICON dry, and ICON resin finally. Receives: Procedure: Resin infiltration; Procedure: microabrasion |
| Etch-bleach | Experimental | Microabrasion of the tooth will be done first, followed by enamel etching using phosphoric acid etch. This will then be followed by sodium hypochlorite application and finally, ICON etch, dry and resin. Receives: Procedure: Resin infiltration; Procedure: microabrasion; Procedure: Etch-bleach |
| Macroabrasion | Experimental | Tooth preparation using high-speed finishing stone, followed by ICON etch, dry and resin. Receives: Procedure: Resin infiltration; Procedure: Macroabrasion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color Change
Evaluating color change of the demarcated enamel opacity in permanent incisors of MIH patients using Vita easy shade.
Measured: Preoperatively - Immediately postoperatively - 1, 3, 6 12 months postoperatively
Secondary outcomes (1)
Oral health related quality of life
Evaluating oral health related quality of life (OHRQoL) using Child Oral-Health-Related Quality of Life Questionnaire.
Measured: Preoperatively - Immediately Postoperatively - 1, 3, 6, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2024
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayada Hefnawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715370
- Sponsor's protocol ID
- PED24_D3
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and executionof all applicable agreements prerequisites to the sharing of data with the requesting party.
Publications
Giannetti L, Murri Dello Diago A, Corciolani E, Spinas E. Deep infiltration for the treatment of hypomineralized enamel lesions in a patient with molar incisor hypomineralization: a clinical case. J Biol Regul Homeost Agents. 2018 May-Jun;32(3):751-754.
PubMed 29921410Athayde GDS, Reis PPGD, Jorge RC, Americano GCA, Fidalgo TKDS, Soviero VM. Impact of masking hypomineralization opacities in anterior teeth on the esthetic perception of children and parents: A randomized controlled clinical trial. J Dent. 2022 Aug;123:104168. doi: 10.1016/j.jdent.2022.104168. Epub 2022 May 25.
PubMed 35643218Prud'homme T, Hyon I, Dajean Trutaud S, Lopez Cazaux S. Different applicabilities of the etch-bleach-seal technique for treating opacities on permanent incisor damage by molar incisor hypomineralisation in three young patients. BMJ Case Rep. 2017 Dec 29;2017:bcr2017221442. doi: 10.1136/bcr-2017-221442.
PubMed 29289946Gencer MDG, Kirzioglu Z. A comparison of the effectiveness of resin infiltration and microabrasion treatments applied to developmental enamel defects in color masking. Dent Mater J. 2019 Mar 31;38(2):295-302. doi: 10.4012/dmj.2018-074. Epub 2019 Feb 1.
PubMed 30713284Sezer B. Treatment Strategies for Incisors of Children Affected by Molar Incisor Hypomineralization : A Narrative Review. Oral. 2024;4:74-89.
Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
PubMed 11641576
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07715370
- Acronym / sponsor ID
- PED24_D3
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Resin Infiltration, Prolonged Resin Infiltration, Microabrasion, Macroabrasion, Etch-Bleach Technique, Esthetic Improvement, Demarcated Enamel Opacities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 20 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Microabrasion | Experimental | Procedure: Resin infiltration, Procedure: microabrasionMicroabrasion to the teeth will be done first, followed by ICON etch, ICON dry, and ICON resin finally. |
| Etch-bleach | Experimental | Procedure: Resin infiltration, Procedure: microabrasion, Procedure: Etch-bleachMicroabrasion of the tooth will be done first, followed by enamel etching using phosphoric acid etch. This will then be followed by sodium hypochlorite application and finally, ICON etch, dry and resin. |
| Macroabrasion | Experimental | Procedure: Resin infiltration, Procedure: MacroabrasionTooth preparation using high-speed finishing stone, followed by ICON etch, dry and resin. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 infiltrationEtching 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. | Procedure or surgery | Etch-bleach, Macroabrasion, Microabrasion |
| microabrasionMicroabrasive 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. | Procedure or surgery | Etch-bleach, Microabrasion |
| Etch-bleachEtching of enamel using 37% phosphoric acid for 60 seconds. After rinsing, 5% NaOCl will be applied to the etched enamel surface for 10 minute. | Procedure or surgery | Etch-bleach |
| MacroabrasionA mild preparation of enamel using a high-speed diamond finishing stone with copious water spray. | Procedure or surgery | Macroabrasion |
Primary outcome
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.
1 secondary outcome
Oral health related quality of life
Time frame: Preoperatively - Immediately Postoperatively - 1, 3, 6, 12 months postoperatively
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 20 Jul 2026.
- Background: PubMed 29921410Giannetti L, Murri Dello Diago A, Corciolani E, Spinas E. Deep infiltration for the treatment of hypomineralized enamel lesions in a patient with molar incisor hypomineralization: a clinical case. J Biol Regul Homeost Agents. 2018 May-Jun;32(3):751-754.
- Background: PubMed 35643218Athayde GDS, Reis PPGD, Jorge RC, Americano GCA, Fidalgo TKDS, Soviero VM. Impact of masking hypomineralization opacities in anterior teeth on the esthetic perception of children and parents: A randomized controlled clinical trial. J Dent. 2022 Aug;123:104168. doi: 10.1016/j.jdent.2022.104168. Epub 2022 May 25.
- Background: PubMed 29289946Prud'homme T, Hyon I, Dajean Trutaud S, Lopez Cazaux S. Different applicabilities of the etch-bleach-seal technique for treating opacities on permanent incisor damage by molar incisor hypomineralisation in three young patients. BMJ Case Rep. 2017 Dec 29;2017:bcr2017221442. doi: 10.1136/bcr-2017-221442.
- Background: PubMed 30713284Gencer MDG, Kirzioglu Z. A comparison of the effectiveness of resin infiltration and microabrasion treatments applied to developmental enamel defects in color masking. Dent Mater J. 2019 Mar 31;38(2):295-302. doi: 10.4012/dmj.2018-074. Epub 2019 Feb 1.
- BackgroundSezer B. Treatment Strategies for Incisors of Children Affected by Molar Incisor Hypomineralization : A Narrative Review. Oral. 2024;4:74-89.
- Background: PubMed 11641576Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included. Approval of the request and executionof all applicable agreements prerequisites to the sharing of data with the requesting party.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, microabrasion and Etch-bleach in people with Molar Incisor Hypomineralization, run by Ain Shams University at 1 site in Egypt.
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 3 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 20 Jul 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 Egypt. 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?
Color Change (time frame: Preoperatively - Immediately postoperatively - 1, 3, 6 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715370, which also lists 6 linked publications.
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 20 Jul 2026.