Molar-Incisor Hypomineralization (MIH)NCT07589179
Evaluation of Occlusal Force and Masticatory Function in Children With Molar-Incisor Hypomineralization
A study testing Glass Hybrid Restorative Treatment in people with Molar-Incisor Hypomineralization (MIH) and Masticatory Performance, run by Marmara University.
Trial summary
This study aims to evaluate right-left chewing balance and masticatory function in children with Molar-Incisor Hypomineralization (MIH) before and after restorative treatment. MIH is a developmental enamel defect that may cause tooth sensitivity, discomfort during chewing, and functional asymmetry. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH), Masticatory Performance, Occlusal Analysis
- What is being tested?
- Glass Hybrid Restorative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2026to 20 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 12 years
- Presence of bilateral molar-incisor hypomineralization (MIH) affecting first permanent molars
- Need for restorative treatment in MIH-affected molars
- Cooperative children with sufficient cognitive ability to complete functional assessments
- Presence of healthy control participants without MIH for comparison
- Mixed dentition period
- Signed informed consent obtained from parents or legal guardians
Who cannot join
- Temporomandibular disorders or orofacial pain
- Systemic diseases or regular medication use affecting mastication
- History of orthodontic treatment or parafunctional habits
- Craniofacial anomalies or developmental dental anomalies
- Extensive prosthetic restorations affecting chewing function
- Uncooperative children unable to complete examination procedures
- Acute dental infection or pain requiring emergency treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Occlusal Force Distribution and Masticatory Function Before and After Restorative Treatment in Children With Molar-Incisor Hypomineralization
This study aims to evaluate right-left chewing balance and masticatory function in children with Molar-Incisor Hypomineralization (MIH) before and after restorative treatment. MIH is a developmental enamel defect that may cause tooth sensitivity, discomfort during chewing, and functional asymmetry.
Children aged 7 to 12 years with bilateral MIH affecting the first permanent molars will receive glass hybrid restorative treatment. Right-left occlusal force distribution will be assessed using a digital occlusal analysis system. In addition, chewing side preference and chewing balance will be evaluated using a standardized chewing gum protocol. These two assessment methods will be used together to provide complementary information about masticatory function.
Measurements will be performed before treatment and during follow-up visits after treatment. The findings obtained from children with MIH will also be compared with healthy children without MIH. The study aims to determine whether restorative treatment improves chewing balance and functional oral performance in children with MIH.
- Conditions
- Molar-Incisor Hypomineralization (MIH), Masticatory Performance, Occlusal Analysis, Chewing Function
- Being tested
- Glass Hybrid Restorative Treatment
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glass Hybrid Restorative TreatmentProcedure or surgery
Restorative treatment of MIH-affected molars using glass hybrid restorative material to evaluate changes in occlusal force distribution and chewing function.
| Study group | Role | What they receive |
|---|---|---|
| MIH Restorative Treatment Group | Experimental | Children with molar-incisor hypomineralization (MIH) will receive glass hybrid restorative treatment. Occlusal force distribution and chewing function will be evaluated before and after treatment using digital occlusal analysis and a chewing gum protocol. Receives: Procedure: Glass Hybrid Restorative Treatment |
| Healthy Control Group | No intervention | Healthy children without MIH will undergo occlusal force distribution and chewing function assessments for comparison with the MIH group. No restorative intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Occlusal Force Distribution Between Right and Left Sides
Percentage distribution of occlusal force between the right and left sides and chewing side assessed using a chewing gum test will be evaluated before and after restorative treatment in children with MIH using a digital occlusal analysis system.
Measured: Baseline and 3 months after restorative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start11 May 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor Hypomineralization (MIH)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589179
- Sponsor's protocol ID
- pedo-TO
- Other IDs
- 09.2024.806
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Occlusal Force Distribution and Masticatory Function Before and After Restorative Treatment in Children With Molar-Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07589179
- Acronym / sponsor ID
- pedo-TO
- Conditions
- Molar-Incisor Hypomineralization (MIH), Masticatory Performance, Occlusal Analysis, Chewing Function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 15 May 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 study aims to evaluate right-left chewing balance and masticatory function in children with Molar-Incisor Hypomineralization (MIH) before and after restorative treatment. MIH is a developmental enamel defect that may cause tooth sensitivity, discomfort during chewing, and functional asymmetry.
Children aged 7 to 12 years with bilateral MIH affecting the first permanent molars will receive glass hybrid restorative treatment. Right-left occlusal force distribution will be assessed using a digital occlusal analysis system. In addition, chewing side preference and chewing balance will be evaluated using a standardized chewing gum protocol. These two assessment methods will be used together to provide complementary information about masticatory function.
Measurements will be performed before treatment and during follow-up visits after treatment. The findings obtained from children with MIH will also be compared with healthy children without MIH. The study aims to determine whether restorative treatment improves chewing balance and functional oral performance in children with MIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIH Restorative Treatment Group | Experimental | Procedure: Glass Hybrid Restorative TreatmentChildren with molar-incisor hypomineralization (MIH) will receive glass hybrid restorative treatment. Occlusal force distribution and chewing function will be evaluated before and after treatment using digital occlusal analysis and a chewing gum protocol. |
| Healthy Control Group | No intervention | –Healthy children without MIH will undergo occlusal force distribution and chewing function assessments for comparison with the MIH group. No restorative intervention will be performed. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 7 to 12 years
- Presence of bilateral molar-incisor hypomineralization (MIH) affecting first permanent molars
- Need for restorative treatment in MIH-affected molars
- Cooperative children with sufficient cognitive ability to complete functional assessments
- Presence of healthy control participants without MIH for comparison
Key exclusion criteria (7 listed)
- Temporomandibular disorders or orofacial pain
- Systemic diseases or regular medication use affecting mastication
- History of orthodontic treatment or parafunctional habits
- Craniofacial anomalies or developmental dental anomalies
- Extensive prosthetic restorations affecting chewing function
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 |
|---|---|---|
| Glass Hybrid Restorative TreatmentRestorative treatment of MIH-affected molars using glass hybrid restorative material to evaluate changes in occlusal force distribution and chewing function. | Procedure or surgery | MIH Restorative Treatment Group |
Primary outcome
Percentage of Occlusal Force Distribution Between Right and Left Sides
Time frame: Baseline and 3 months after restorative treatment
Percentage distribution of occlusal force between the right and left sides and chewing side assessed using a chewing gum test will be evaluated before and after restorative treatment in children with MIH using a digital occlusal analysis system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Glass Hybrid Restorative Treatment in people with Molar-Incisor Hypomineralization (MIH) and Masticatory Performance, run by Marmara University.
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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Afra Nur Savas (+90 534 327 92 74, aafranursavas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Occlusal Force Distribution Between Right and Left Sides (time frame: Baseline and 3 months after restorative treatment). 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 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.