Molar-Incisor Hypomineralization (MIH)NCT07906548
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
A study testing Alkasite Restorative System and Glass Hybrid Restorative System in people with Molar-Incisor Hypomineralization (MIH), run by Çanakkale Onsekiz Mart University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this randomized clinical trial is to compare the clinical performance and survival of two restorative systems in permanent first molars affected by molar-incisor hypomineralization (MIH) in children aged 8 to 14 years. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Molar-Incisor Hypomineralization (MIH)
- What is being tested?
- Alkasite Restorative System and Glass Hybrid Restorative System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2026to 30 Jun 2030
- 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 14 years.
- Diagnosis of molar-incisor hypomineralization (MIH).
- At least two MIH-affected permanent first molars requiring direct restorative treatment because of carious lesions extending into dentin.
- Study teeth must be vital and sufficiently erupted to allow rubber dam isolation and restorative treatment.
- Study teeth must be suitable for one- or two-surface direct restorations involving the occlusal (O), mesio-occlusal (MO), disto-occlusal (DO), bucco-occlusal (BO), or oral/lingual-occlusal (OL) surfaces.
- Written informed consent from a parent or legal guardian and age-appropriate assent from the child.
- Ability to attend the baseline and follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months.
Who cannot join
- Spontaneous pain, fistula, swelling, pathological mobility, or other clinical findings suggestive of irreversible pulpitis or pulp necrosis in a study tooth.
- Need for pulp therapy in a study tooth.
- Extensive loss of tooth structure involving three or more surfaces or requiring indirect restoration and/or crown treatment.
- Pulp exposure present before treatment.
- Inability to achieve adequate rubber dam isolation of a study tooth.
- A pre-existing extensive restoration in a study tooth that could interfere with clinical evaluation of the restoration.
- An uncontrolled systemic disease that could interfere with safe and appropriate restorative treatment or attendance at planned follow-up visits.
- Known allergy or hypersensitivity to any component of the restorative materials or auxiliary products used in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University
Çanakkale, Kepez, 17100
Cansu Özmines Bayraktar, Research Assistant, +90 543 625 6533, cansuozmines@outlook.com
Cansu Özmines Bayraktar, Research Assistant, +90 543 625 65 33, cansuozmines@outlook.com
About this study
Official title: Comparison of the Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in Permanent First Molars Affected by Molar-Incisor Hypomineralization: A Split-Mouth Randomized Clinical Trial
The purpose of this randomized clinical trial is to compare the clinical performance and survival of two restorative systems in permanent first molars affected by molar-incisor hypomineralization (MIH) in children aged 8 to 14 years.
MIH is a developmental condition that affects the enamel of permanent first molars and may also affect permanent incisors. Affected molars may develop enamel breakdown, sensitivity, and dental caries and may require restorative treatment.
Read more
Children included in the study will have at least two MIH-affected permanent first molars that require direct restorative treatment. In each child, one eligible tooth will be restored with the glass hybrid restorative system EQUIA Forte HT, and the other eligible tooth will be restored with the alkasite restorative system Cention Forte. The restorative system assigned to each tooth will be determined at random.
Restorative treatment will be performed after selective caries removal and under rubber dam isolation. Researchers will compare the two restorations within the same child over time.
The restorations will be evaluated for clinical performance and restoration survival. Follow-up assessments will be performed at 1, 3, 6, 12, 18, 24, and 36 months after treatment.
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Being tested
- Alkasite Restorative System, Glass Hybrid Restorative System
- Keywords
- Molar-Incisor Hypomineralization (MIH), Glass Hybrid Restorative Material, Alkasite Restorative Material, EQUIA Forte HT, Cention Forte, Dental Restoration, Pediatric Dentistry, Permanent First Molars, Split-Mouth Randomized Clinical Trial
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkasite Restorative SystemDevice
Also called Cention Forte
Cention Forte will be used with Cention Primer for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Primer application, material preparation and placement, polymerization/setting, finishing, and polishing will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session.
Glass Hybrid Restorative SystemDevice
Also called EQUIA Forte HT
EQUIA Forte HT will be used with EQUIA Forte Coat for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Material preparation and placement, setting, finishing, and application of the surface coating will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Cention Forte Group | Experimental | One of the two eligible MIH-affected permanent first molars in each participant will be randomly assigned to the Cention Forte group at the tooth level. Following selective caries removal under rubber dam isolation, the tooth will be restored using the Cention Forte alkasite restorative system with Cention Primer according to the manufacturer's instructions. Treatment will be completed in a single session. Receives: Device: Alkasite Restorative System |
| EQUIA Forte HT Group | Active comparator | The paired eligible MIH-affected permanent first molar in the same participant will be assigned to the EQUIA Forte HT group at the tooth level. Following selective caries removal under rubber dam isolation, the tooth will be restored using the EQUIA Forte HT glass hybrid restorative system with EQUIA Forte Coat according to the manufacturer's instructions. Treatment will be completed in a single session. Receives: Device: Glass Hybrid Restorative System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Material Fracture and Retention According to Revised FDI Criteria
Material fracture and retention of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal Adaptation According to Revised FDI Criteria
Marginal adaptation of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Proximal Contact Point According to Revised FDI Criteria
Proximal contact point, when applicable, will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Form and Contour According to Revised FDI Criteria
Form and contour of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Occlusion and Wear According to Revised FDI Criteria
Occlusion and wear of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Caries Associated With Restorations According to Revised FDI Criteria
Caries associated with restorations at the restoration margin will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Dental Hard-Tissue Defects at the Restoration Margin According to Revised FDI Criteria
Dental hard-tissue defects at the restoration margin will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Postoperative Hypersensitivity and Pulpal Status According to Revised FDI Criteria
Postoperative hypersensitivity and pulpal status of teeth restored with Cention Forte and EQUIA Forte HT will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Surface Gloss and Surface Texture According to Revised FDI Criteria
Surface gloss and surface texture of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal Staining According to Revised FDI Criteria
Marginal staining of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Color Match According to Revised FDI Criteria
Color match of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Retention According to Modified USPHS Criteria
Retention of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Retention will be recorded using the applicable Alpha (A), Bravo (B), Charlie (C), and Delta (D) categories defined in the study case report form. Alpha represents complete retention of the restoration, whereas Delta represents complete loss of the restoration. The same predefined categories will be used at each follow-up assessment.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal Adaptation According to Modified USPHS Criteria
Marginal adaptation of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates that the restoration is fully adapted to the tooth with no visible gap and the explorer does not catch. Bravo indicates that the explorer catches at the margin without a distinct gap exposing dentin or base. Charlie indicates a distinct gap into which the explorer enters with exposure of dentin or base. Delta indicates that the restoration is fractured, lost, or cannot be evaluated.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal Discoloration According to Modified USPHS Criteria
Marginal discoloration of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates no marginal discoloration. Bravo indicates mild marginal discoloration that is clinically acceptable. Charlie indicates marked marginal discoloration that is clinically unacceptable. Delta is not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Anatomical Form According to Modified USPHS Criteria
Anatomical form of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates continuity of the restoration with the existing anatomical form. Bravo indicates slight material loss without exposure of dentin or base. Charlie indicates material loss resulting in exposure of dentin or base. Delta is not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Surface Texture According to Modified USPHS Criteria
Surface texture of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates a smooth surface. Bravo indicates a mildly rough or scratched surface that can be corrected by refinishing or polishing. Charlie indicates a markedly rough or irregular surface that cannot be corrected by refinishing. Delta is not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Color Match According to Modified USPHS Criteria
Color match of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates that the color and translucency of the restoration are compatible with the surrounding tooth structure. Bravo indicates a difference in color or translucency that is clinically acceptable. Charlie indicates a color difference that is clinically unacceptable. Delta is not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Secondary Caries According to Modified USPHS Criteria
Secondary caries associated with Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates absence of secondary caries and Charlie indicates presence of secondary caries. Bravo and Delta are not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Postoperative Sensitivity According to Modified USPHS Criteria
Postoperative sensitivity of teeth restored with Cention Forte and EQUIA Forte HT will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates absence of postoperative sensitivity and Charlie indicates presence of postoperative sensitivity. Bravo and Delta are not applicable to this criterion.
Measured: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Restoration Survival
Restoration survival will be evaluated as the time from restoration placement to the first predefined failure event. Failure will include complete loss of the restoration; need for replacement because of clinically unacceptable fracture or material loss; need for replacement because of caries at the restoration margin; complete replacement of the restoration for another reason; need for pulp treatment due to a restoration-related pulpal complication; or extraction of the study tooth. Minor adjustment, polishing, or repair that is clinically acceptable and does not require complete replacement of the restoration will not be considered a failure event. Restorations without failure will be censored at the date of the last clinical evaluation.
Measured: Through 36 months after restoration placement
Secondary outcomes (1)
MIH-Related Hypersensitivity Assessed With the Schiff Cold Air Sensitivity Scale
MIH-related hypersensitivity of the study teeth will be evaluated using the Schiff Cold Air Sensitivity Scale (SCASS). The scale ranges from 0 to 3. A score of 0 indicates absence of hypersensitivity, whereas scores 1-3 indicate the presence of hypersensitivity. Higher scores indicate greater hypersensitivity. SCASS scores will be recorded separately for the paired study teeth at baseline and during follow-up.
Measured: Baseline and 1, 3, 6, 12, 18, 24, and 36 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 posted30 Oct 2026
- Study start31 Dec 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çanakkale Onsekiz Mart University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Özmines Bayraktar, Çanakkale Onsekiz Mart University
- Investigators
- Cansu Özmines Bayraktar, Research Assistant, Principal investigator, Çanakkale Onsekiz Mart University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906548
- Sponsor's protocol ID
- COMU-PEDO-2026-02
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared with other researchers. Access to the research data will be restricted to authorized members of the research team, and the data will be processed, stored, and protected in accordance with participant confidentiality, applicable legislation, and institutional data security requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in Permanent First Molars Affected by Molar-Incisor Hypomineralization: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07906548
- Acronym / sponsor ID
- COMU-PEDO-2026-02
- Conditions
- Molar-Incisor Hypomineralization (MIH)
- Keywords
- Molar-Incisor Hypomineralization (MIH), Glass Hybrid Restorative Material, Alkasite Restorative Material, EQUIA Forte HT, Cention Forte, Dental Restoration, Pediatric Dentistry, Permanent First Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Çanakkale Onsekiz Mart UniversityUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 30 Oct 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.
The purpose of this randomized clinical trial is to compare the clinical performance and survival of two restorative systems in permanent first molars affected by molar-incisor hypomineralization (MIH) in children aged 8 to 14 years.
MIH is a developmental condition that affects the enamel of permanent first molars and may also affect permanent incisors. Affected molars may develop enamel breakdown, sensitivity, and dental caries and may require restorative treatment.
Children included in the study will have at least two MIH-affected permanent first molars that require direct restorative treatment. In each child, one eligible tooth will be restored with the glass hybrid restorative system EQUIA Forte HT, and the other eligible tooth will be restored with the alkasite restorative system Cention Forte. The restorative system assigned to each tooth will be determined at random.
Restorative treatment will be performed after selective caries removal and under rubber dam isolation. Researchers will compare the two restorations within the same child over time.
The restorations will be evaluated for clinical performance and restoration survival. Follow-up assessments will be performed at 1, 3, 6, 12, 18, 24, and 36 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cention Forte Group | Experimental | Device: Alkasite Restorative SystemOne of the two eligible MIH-affected permanent first molars in each participant will be randomly assigned to the Cention Forte group at the tooth level. Following selective caries removal under rubber dam isolation, the tooth will be restored using the Cention Forte alkasite restorative system with Cention Primer according to the manufacturer's instructions. Treatment will be completed in a single session. |
| EQUIA Forte HT Group | Active comparator | Device: Glass Hybrid Restorative SystemThe paired eligible MIH-affected permanent first molar in the same participant will be assigned to the EQUIA Forte HT group at the tooth level. Following selective caries removal under rubber dam isolation, the tooth will be restored using the EQUIA Forte HT glass hybrid restorative system with EQUIA Forte Coat according to the manufacturer's instructions. Treatment will be completed in a single session. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 8 to 14 years.
- Diagnosis of molar-incisor hypomineralization (MIH).
- At least two MIH-affected permanent first molars requiring direct restorative treatment because of carious lesions extending into dentin.
- Study teeth must be vital and sufficiently erupted to allow rubber dam isolation and restorative treatment.
- Study teeth must be suitable for one- or two-surface direct restorations involving the occlusal (O), mesio-occlusal (MO), disto-occlusal (DO), bucco-occlusal (BO), or oral/lingual-occlusal (OL) surfaces.
Key exclusion criteria (8 listed)
- Spontaneous pain, fistula, swelling, pathological mobility, or other clinical findings suggestive of irreversible pulpitis or pulp necrosis in a study tooth.
- Need for pulp therapy in a study tooth.
- Extensive loss of tooth structure involving three or more surfaces or requiring indirect restoration and/or crown treatment.
- Pulp exposure present before treatment.
- Inability to achieve adequate rubber dam isolation of a study tooth.
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 |
|---|---|---|
| Alkasite Restorative SystemAlso: Cention ForteCention Forte will be used with Cention Primer for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Primer application, material preparation and placement, polymerization/setting, finishing, and polishing will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session. | Device | Cention Forte Group |
| Glass Hybrid Restorative SystemAlso: EQUIA Forte HTEQUIA Forte HT will be used with EQUIA Forte Coat for direct restoration of the assigned MIH-affected permanent first molar following selective caries removal under rubber dam isolation. Material preparation and placement, setting, finishing, and application of the surface coating will be performed according to the manufacturer's instructions. The restoration will be completed in a single treatment session. | Device | EQUIA Forte HT Group |
Primary outcome
Material Fracture and Retention According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Material fracture and retention of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Marginal Adaptation According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal adaptation of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Proximal Contact Point According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Proximal contact point, when applicable, will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Form and Contour According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Form and contour of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Occlusion and Wear According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Occlusion and wear of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Caries Associated With Restorations According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Caries associated with restorations at the restoration margin will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Dental Hard-Tissue Defects at the Restoration Margin According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Dental hard-tissue defects at the restoration margin will be evaluated for Cention Forte and EQUIA Forte HT restorations according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Postoperative Hypersensitivity and Pulpal Status According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Postoperative hypersensitivity and pulpal status of teeth restored with Cention Forte and EQUIA Forte HT will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Surface Gloss and Surface Texture According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Surface gloss and surface texture of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Marginal Staining According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal staining of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Color Match According to Revised FDI Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Color match of Cention Forte and EQUIA Forte HT restorations will be evaluated according to the revised Fédération Dentaire Internationale (FDI) criteria. This criterion will be scored from 1 to 5: 1 = clinically excellent/very good, 2 = clinically good, 3 = clinically satisfactory, 4 = clinically unsatisfactory, and 5 = clinically poor. Scores 1-3 are considered clinically acceptable and scores 4-5 clinically unacceptable. Higher scores indicate a less favorable clinical outcome. NA will be recorded when the criterion is not applicable or cannot be evaluated.
Retention According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Retention of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Retention will be recorded using the applicable Alpha (A), Bravo (B), Charlie (C), and Delta (D) categories defined in the study case report form. Alpha represents complete retention of the restoration, whereas Delta represents complete loss of the restoration. The same predefined categories will be used at each follow-up assessment.
Marginal Adaptation According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal adaptation of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates that the restoration is fully adapted to the tooth with no visible gap and the explorer does not catch. Bravo indicates that the explorer catches at the margin without a distinct gap exposing dentin or base. Charlie indicates a distinct gap into which the explorer enters with exposure of dentin or base. Delta indicates that the restoration is fractured, lost, or cannot be evaluated.
Marginal Discoloration According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Marginal discoloration of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates no marginal discoloration. Bravo indicates mild marginal discoloration that is clinically acceptable. Charlie indicates marked marginal discoloration that is clinically unacceptable. Delta is not applicable to this criterion.
Anatomical Form According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Anatomical form of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates continuity of the restoration with the existing anatomical form. Bravo indicates slight material loss without exposure of dentin or base. Charlie indicates material loss resulting in exposure of dentin or base. Delta is not applicable to this criterion.
Surface Texture According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Surface texture of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates a smooth surface. Bravo indicates a mildly rough or scratched surface that can be corrected by refinishing or polishing. Charlie indicates a markedly rough or irregular surface that cannot be corrected by refinishing. Delta is not applicable to this criterion.
Color Match According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Color match of Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates that the color and translucency of the restoration are compatible with the surrounding tooth structure. Bravo indicates a difference in color or translucency that is clinically acceptable. Charlie indicates a color difference that is clinically unacceptable. Delta is not applicable to this criterion.
Secondary Caries According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Secondary caries associated with Cention Forte and EQUIA Forte HT restorations will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates absence of secondary caries and Charlie indicates presence of secondary caries. Bravo and Delta are not applicable to this criterion.
Postoperative Sensitivity According to Modified USPHS Criteria
Time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Postoperative sensitivity of teeth restored with Cention Forte and EQUIA Forte HT will be evaluated using the predefined modified United States Public Health Service (USPHS/Ryge) criteria. Alpha indicates absence of postoperative sensitivity and Charlie indicates presence of postoperative sensitivity. Bravo and Delta are not applicable to this criterion.
Restoration Survival
Time frame: Through 36 months after restoration placement
Restoration survival will be evaluated as the time from restoration placement to the first predefined failure event. Failure will include complete loss of the restoration; need for replacement because of clinically unacceptable fracture or material loss; need for replacement because of caries at the restoration margin; complete replacement of the restoration for another reason; need for pulp treatment due to a restoration-related pulpal complication; or extraction of the study tooth. Minor adjustment, polishing, or repair that is clinically acceptable and does not require complete replacement of the restoration will not be considered a failure event. Restorations without failure will be censored at the date of the last clinical evaluation.
1 secondary outcome
MIH-Related Hypersensitivity Assessed With the Schiff Cold Air Sensitivity Scale
Time frame: Baseline and 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
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 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared with other researchers. Access to the research data will be restricted to authorized members of the research team, and the data will be processed, stored, and protected in accordance with participant confidentiality, applicable legislation, and institutional data security requirements.
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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.
Cansu Özmines Bayraktar, Research Assistant principal investigator
Çanakkale Onsekiz Mart University, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkasite Restorative System and Glass Hybrid Restorative System in people with Molar-Incisor Hypomineralization (MIH), run by Çanakkale Onsekiz Mart 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 7 inclusion and 8 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 30 Oct 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?
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 Cansu Özmines Bayraktar, Research Assistant (+90 543 625 6533, cansuozmines@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Material Fracture and Retention According to Revised FDI Criteria (time frame: 1, 3, 6, 12, 18, 24, and 36 months after restoration placement). The study lists 20 primary outcomes in all. 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 30 Oct 2026.