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
Sponsor study identifier
interventional
30
1 country
1
Study Start
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2026
Actual (reported)October 30, 2026
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
1, 3, 6, 12, 18, 24, and 36 months after restoration placement
MIH-Related Hypersensitivity Assessed With the Schiff Cold Air Sensitivity Scale
Baseline and 1, 3, 6, 12, 18, 24, and 36 months after restoration placement
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.
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.
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.
Çanakkale Onsekiz Mart University
Çanakkale, Kepez, 17100, Turkey (Türkiye)
Cansu Özmines Bayraktar, Research Assistant
Çanakkale Onsekiz Mart University, Faculty of Dentistry
First Submitted
October 15, 2026
First Posted
October 30, 2026
Study Start
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
June 30, 2028
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Through 36 months after restoration placement
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.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 30, 2026
Record last verified: 2026-10
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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