Molar Incisor HypomineralizationNCT07733804
Clinical Performance of Restorations in Teeth Affected by Molar Incisor Hypomineralization
A study testing Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) and Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT) in people with Molar Incisor Hypomineralization, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) and Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 1 Aug 2020
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children.
- Good oral hygiene, no periodontal disease or bad habits.
- The presence of at least two permanent molars with MIH involving dentin with a split-mouth design study according to the clinical and radiological examination.
- Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact.
- According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
Who cannot join
- History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
- Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry Department of Pediatric Dentistry
Istanbul, 34854
About this study
Official title: Clinical Performance of Glass Ionomer and Composite Restorations in First Permanent Molars Affected by Molar Incisor Hypomineralization
This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH).
Read the detailed description
This study is being carried out in the Department of Pediatric Dentistry, Dental School, Marmara University in Türkiye. The study reviewed and approved by The Human Research Ethics Committee of Marmara University, Dental School with the protocol number of 2019-355. Informed consent forms were obtained from parents or guardians before the child participated in the study.
Study design: A split-mouth, randomized, controlled clinical study was done. The children who were diagnosed with MIH on the basis of clinical examination at the Pediatric Dentistry Clinics of Dental School, Marmara University, Turkey were enrolled in the study. No children were excluded based on gender, social or economic status.
The inclusion criteria were:
- Cooperative children
- Good oral hygiene, no periodontal disease or bad habits,
- Presence of at least two permanent molars with MIH involving dentin with 31 split-mouth design study according to the clinical and radiological examination.
- Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact
- According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
The exclusion criteria were;
- History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
- Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior), Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)
- Keywords
- Molar Incisor hypomineralization, glass hybrid, short fiber reinforced composite
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior)Procedure or surgery
Following selective caries removal, the cavity was restored with a short fiber-reinforced flowable composite (EverX Flow) as a dentin replacement, followed by placement of a conventional microhybrid composite resin (G-ænial Posterior) as the occlusal enamel replacement.
Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)Procedure or surgery
Following selective caries removal, the cavity was restored with a glass hybrid restorative material (EQUIA Forte HT). After finishing and polishing, a light-cured resin coating (EQUIA Forte Coat) was applied to the restoration.
| Study group | Role | What they receive |
|---|---|---|
| glass hybrid | Active comparator | Isolation was maintained using cotton rolls and a saliva ejector. MIH lesions were restored with Equia Forte HT (GC Corporation, Europe) according to manufacturer's orders. For mixing the encapsulated Equia Forte HT Bulk Fill Glass Hybrid, Capsule Mixer CM-II (GC Europe) was used for 10 sec under +/- 4,000RPM. The automatically mixed study material (10 s) was slowly injected into the cavity. The overflowing excesses were cleaned by hand tools. After 45 sec the restoration material was formed into shape. After a 2.5-min setting time, the occlusion was checked using fine carbon paper and then adjusted. Equia Coat (GC) was applied and light cured for 20 s (D-Light Duo, GC, 1,400 mW/cm2 ). After finishing the restoration procedure, the children were instructed not to eat for at least 1 h. Receives: Procedure: Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT) |
| short fiber reinforced composite (SFRC) | Active comparator | Teeth were restored as same protocol with micro-hybrid composite (G-aenial, GC, Europe). LED light (GC- D-Light) was used at standard mode 1400 mW/cm2, at 50-60 ºC, for 20 sec. Immediately after heat application, occlusal interferences were checked. The restorations were trimmed and adapted using high-speed, water-cooled fine diamond burs (125 μm, Intensiv SA, Switzerland),) than polished after the estimated setting time. Receives: Procedure: Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria
The clinical performance of the restorations will be evaluated using the modified United States Public Health Service (USPHS) criteria, including retention, marginal adaptation, marginal discoloration, anatomical form, color match, secondary caries, and postoperative sensitivity. Each criterion will be rated as Alpha, Bravo, or Charlie, with Alpha indicating the best clinical outcome and Charlie indicating an unacceptable outcome or restoration failure. For most criteria, Alpha and Bravo ratings will be considered clinically satisfactory, whereas Charlie ratings will be considered clinically unsatisfactory. For secondary caries, Alpha indicates the absence of caries and Bravo indicates the presence of secondary caries.
Measured: Baseline and 12, 24, 36, and 60 months after restoration placement
Restoration Survival
Restoration survival will be assessed at each follow-up visit (12, 24, 36, and 60 months after restoration placement) using Kaplan-Meier survival analysis. A restoration will be considered to have survived if it remains clinically functional without requiring replacement. Survival probabilities will be estimated using the Kaplan-Meier method and compared between groups using the log-rank test.
Measured: Baseline and 12, 24, 36, and 60 months after restoration placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Apr 2020
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Marmara 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
- Model description
- Split-mouth
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733804
- Sponsor's protocol ID
- MIH_SFRC
- Status last verified
- Jul 2026
- First submitted
- 4 May 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dokumacigil NK, Yavuz BS, Kaya R, Kargul B. Clinical performance of glass hybrid and short fiber-reinforced composite restorations in MIH-affected molars: A 60-month split-mouth randomized controlled trial. Clin Oral Investig. 2026 Sep 22;30(10):457. doi: 10.1007/s00784-026-07145-7.
PubMed 42771191
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Glass Ionomer and Composite Restorations in First Permanent Molars Affected by Molar Incisor Hypomineralization
- ClinicalTrials.gov ID
- NCT07733804
- Acronym / sponsor ID
- MIH_SFRC
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor hypomineralization, glass hybrid, short fiber reinforced composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 29 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.
This study evaluated the clinical performances of a glass hybrid restoration and direct posterior micro-hybrid composite restorations with short fiber reinforced composite (SFRC) after Selective Caries Removal in restorations of first permanent molars (FPMs) that were affected by Molar Incisor Hypomineralization (MIH).
Detailed description
This study is being carried out in the Department of Pediatric Dentistry, Dental School, Marmara University in Türkiye. The study reviewed and approved by The Human Research Ethics Committee of Marmara University, Dental School with the protocol number of 2019-355. Informed consent forms were obtained from parents or guardians before the child participated in the study.
Study design: A split-mouth, randomized, controlled clinical study was done. The children who were diagnosed with MIH on the basis of clinical examination at the Pediatric Dentistry Clinics of Dental School, Marmara University, Turkey were enrolled in the study. No children were excluded based on gender, social or economic status.
The inclusion criteria were:
- Cooperative children
- Good oral hygiene, no periodontal disease or bad habits,
- Presence of at least two permanent molars with MIH involving dentin with 31 split-mouth design study according to the clinical and radiological examination.
- Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact
- According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
The exclusion criteria were;
- History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
- Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Split-mouth
| Arm | Type | Receives |
|---|---|---|
| glass hybrid | Active comparator | Procedure: Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)Isolation was maintained using cotton rolls and a saliva ejector. MIH lesions were restored with Equia Forte HT (GC Corporation, Europe) according to manufacturer's orders. For mixing the encapsulated Equia Forte HT Bulk Fill Glass Hybrid, Capsule Mixer CM-II (GC Europe) was used for 10 sec under +/- 4,000RPM. The automatically mixed study material (10 s) was slowly injected into the cavity. The overflowing excesses were cleaned by hand tools. After 45 sec the restoration material was formed into shape. After a 2.5-min setting time, the occlusion was checked using fine carbon paper and then adjusted. Equia Coat (GC) was applied and light cured for 20 s (D-Light Duo, GC, 1,400 mW/cm2 ). After finishing the restoration procedure, the children were instructed not to eat for at least 1 h. |
| short fiber reinforced composite (SFRC) | Active comparator | Procedure: Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior)Teeth were restored as same protocol with micro-hybrid composite (G-aenial, GC, Europe). LED light (GC- D-Light) was used at standard mode 1400 mW/cm2, at 50-60 ºC, for 20 sec. Immediately after heat application, occlusal interferences were checked. The restorations were trimmed and adapted using high-speed, water-cooled fine diamond burs (125 μm, Intensiv SA, Switzerland),) than polished after the estimated setting time. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Cooperative children.
- Good oral hygiene, no periodontal disease or bad habits.
- The presence of at least two permanent molars with MIH involving dentin with a split-mouth design study according to the clinical and radiological examination.
- Had a normal occlusal relationship with natural dentition, and had at least one adjacent tooth contact.
- According to the split mouth working design, an equal number of teeth were selected from the right and left sides.
Key exclusion criteria (2 listed)
- History of bruxism, known inability to return for recall appointments and allergies to ingredients of glass ionomer based restorative materials.
- Cavity with restorations, hypoplasia, fracture or cracks, abrasion, erosion, abfraction, fistula, abscess or pathological mobility, pain, pulp exposure were excluded
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 |
|---|---|---|
| Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior)Following selective caries removal, the cavity was restored with a short fiber-reinforced flowable composite (EverX Flow) as a dentin replacement, followed by placement of a conventional microhybrid composite resin (G-ænial Posterior) as the occlusal enamel replacement. | Procedure or surgery | short fiber reinforced composite (SFRC) |
| Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT)Following selective caries removal, the cavity was restored with a glass hybrid restorative material (EQUIA Forte HT). After finishing and polishing, a light-cured resin coating (EQUIA Forte Coat) was applied to the restoration. | Procedure or surgery | glass hybrid |
Primary outcome
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria
Time frame: Baseline and 12, 24, 36, and 60 months after restoration placement
The clinical performance of the restorations will be evaluated using the modified United States Public Health Service (USPHS) criteria, including retention, marginal adaptation, marginal discoloration, anatomical form, color match, secondary caries, and postoperative sensitivity. Each criterion will be rated as Alpha, Bravo, or Charlie, with Alpha indicating the best clinical outcome and Charlie indicating an unacceptable outcome or restoration failure. For most criteria, Alpha and Bravo ratings will be considered clinically satisfactory, whereas Charlie ratings will be considered clinically unsatisfactory. For secondary caries, Alpha indicates the absence of caries and Bravo indicates the presence of secondary caries.
Restoration Survival
Time frame: Baseline and 12, 24, 36, and 60 months after restoration placement
Restoration survival will be assessed at each follow-up visit (12, 24, 36, and 60 months after restoration placement) using Kaplan-Meier survival analysis. A restoration will be considered to have survived if it remains clinically functional without requiring replacement. Survival probabilities will be estimated using the Kaplan-Meier method and compared between groups using the log-rank test.
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 29 Jul 2026.
- Derived from this study: PubMed 42771191Dokumacigil NK, Yavuz BS, Kaya R, Kargul B. Clinical performance of glass hybrid and short fiber-reinforced composite restorations in MIH-affected molars: A 60-month split-mouth randomized controlled trial. Clin Oral Investig. 2026 Sep 22;30(10):457. doi: 10.1007/s00784-026-07145-7.
- Individual participant dataSharing planned: No
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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 Restoration with Short Fiber-Reinforced Composite and Micro-Hybrid Composite (EverX Flow + G-ænial Posterior) and Restoration with Glass Hybrid Restorative Material (EQUIA Forte HT) in people with Molar Incisor Hypomineralization, run by Marmara 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 5 inclusion and 2 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 29 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 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?
Clinical Performance of Restorations Assessed Using the Modified United States Public Health Service Criteria (time frame: Baseline and 12, 24, 36, and 60 months after restoration placement). The study lists 2 primary outcomes in all. 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 NCT07733804, which also lists 1 linked publication.
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 29 Jul 2026.