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This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.
The study will consist of a randomised controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the FDI criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). And the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - conservative group). Patient evaluations will be performed yearly after 12 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FDI - tradional group | Active Comparator | Diagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI). |
|
| CARS - conservative group | Experimental | Diagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dental treatment | Procedure | Dental treatment of all dental needs present in adults related or not to the dental caries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in number of surfaces restored requiring new intervention | The primary endpoint will be the number of surfaces restored requiring intervention, which is composed of the sum of components with different levels of severity: number of surfaces with new caries lesions, number of surfaces restored in need of repair, replacement, teeth with episodes of pain, teeth requiring endodontic treatment or extraction. | 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14) | 12 months, 24 months | |
| Cost-effectiveness measured by a scale | Effectiveness will be measured through the number of restored surfaces without intervention. The cost-effectiveness ratio will be expressed by the cost ratio of the FDI and CARS criteria and effectiveness (number of surfaces without the need for new interventions) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maximiliano Cenci, PhD | Federal University of Pelotas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pelotas | Pelotas | Rio Grande do Sul | 96015560 | Brazil | ||
| School of Dentistry - Federal University of Pelotas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33172449 | Background | Signori C, Moro BLP, Uehara JLS, Romero VHD, de Oliveira EF, Braga MM, Mendes FM, Cenci MS; CaCIA Collaborative Group. Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial. BMC Oral Health. 2020 Nov 10;20(1):317. doi: 10.1186/s12903-020-01307-z. | |
| 20628774 |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003729 | Dental Care |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D003752 | Dental Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Patients, clinical operators responsible for dental treatment, and the examiner who will assess the outcomes will be blind to the allocation group of the participants.
| Dental treatment | Procedure | Dental treatment of all dental needs present in adults related or not to the dental caries |
|
| 12 months, 24 months |
| Pelotas |
| Rio Grande do Sul |
| 96015560 |
| Brazil |
| Result |
| Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. |
| 26464398 | Result | Brouwer F, Askar H, Paris S, Schwendicke F. Detecting Secondary Caries Lesions: A Systematic Review and Meta-analysis. J Dent Res. 2016 Feb;95(2):143-51. doi: 10.1177/0022034515611041. Epub 2015 Oct 13. |