Secondary Caries Clinical Trial
— CaCIAOfficial title:
Caries Associated With Restorations or Sialants Cognition and Identification in Adults
Verified date | April 2023 |
Source | Federal University of Pelotas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 185 |
Est. completion date | December 1, 2032 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients seeking dental treatment at the School of Dentistry; - Age between 18 and 60 years; - Patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth. Exclusion Criteria: - Patients who refuse to participate in the research; - Patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service; - Patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the Faculty of Dentistry; - Patients who reside in other locations and who can not return for periodic follow-up of the interventions. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Pelotas | Pelotas | Rio Grande Do Sul |
Brazil | School of Dentistry - Federal University of Pelotas | Pelotas | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Pelotas |
Brazil,
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. — View Citation
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. 2 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14) | 12 months, 24 months | ||
Secondary | 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) | 12 months, 24 months |
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