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Caries Cognition and Identification in Adults (CaCIA)

F

Federal University of Pelotas

Status

Active, not recruiting

Conditions

Secondary Caries

Treatments

Procedure: Dental treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03108586
UFPEL- PPGO 0020

Details and patient eligibility

About

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.

Full 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.

Enrollment

185 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

185 participants in 2 patient groups

FDI - tradional group
Active Comparator group
Description:
Diagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI).
Treatment:
Procedure: Dental treatment
Procedure: Dental treatment
CARS - conservative group
Experimental group
Description:
Diagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria.
Treatment:
Procedure: Dental treatment
Procedure: Dental treatment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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