An interventional study of Alkasite Restorative System and Glass Hybrid Restorative System in Molar-Incisor Hypomineralization (MIH), sponsored by Çanakkale Onsekiz Mart University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Çanakkale Onsekiz Mart University · Not applicable, Interventional, and Treatment
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.
133 studies on the registry are indexed under Molar Hypomineralization; 46 are open to participants now.
This study's planned enrollment of 30 is below the median of 53 across 104 interventional studies indexed under Molar Hypomineralization.
Browse Molar Hypomineralization studies →Çanakkale Onsekiz Mart University is the lead sponsor of 51 studies on the registry; 15 are open to participants now.
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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 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.
Exclusion Criteria:
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 to any component of the restorative materials or auxiliary products used in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Alkasite Restorative System
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.
Device: Glass Hybrid Restorative System
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.
Also known as: Cention Forte
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.
Also known as: EQUIA Forte HT
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 36 months after restoration placement
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.
Time frame: Baseline and 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
Plan to share: 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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Çanakkale Onsekiz Mart University