Trial · NCT07906548
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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