Caries Cognition and Identification in Adults

Secondary Caries Clinical Trial

— CaCIA  

Official title:

Caries Associated With Restorations or Sialants Cognition and Identification in Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108586
• Other study ID #: UFPEL- PPGO 0020
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 1, 2032

Study information

• Verified date: April 2023
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Secondary Caries

Intervention

Procedure:
• Dental treatment
Dental treatment of all dental needs present in adults related or not to the dental caries
• Dental treatment
Dental treatment of all dental needs present in adults related or not to the dental caries

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas	Pelotas	Rio Grande Do Sul
Brazil	School of Dentistry - Federal University of Pelotas	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Outcome

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