Caries Cognition and Identification in Adults

Not Applicable

Active, not recruiting

• Conditions: Secondary Caries

• Registration Number: NCT03108586
• Lead Sponsor: Federal University of Pelotas

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-05
• Study First Posted: 2017-04-11
• Primary Completion: 2022-12-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-26
• Study Completion: 2032-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in number of surfaces restored requiring new intervention	12 months, 24 months	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.

Secondary Outcome Measures

Name	Time	Method
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	12 months, 24 months	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)

Trial Locations

Locations (2)

Federal University of Pelotas; 🇧🇷 Pelotas, Rio Grande Do Sul, Brazil

School of Dentistry - Federal University of Pelotas; 🇧🇷 Pelotas, RS, Brazil