Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars

Condition(s) studied

Investigational drug(s) / intervention(s)

Alkasite 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.

Glass Hybrid Restorative System: 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 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.

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.

Eligibility

Primary outcome measure(s)

• Material Fracture and Retention According to Revised FDI Criteria — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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