Caries Cognition and Identification in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2032-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Secondary Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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FDI - tradional group

Diagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI).

Group Type ACTIVE_COMPARATOR

Dental treatment

Intervention Type PROCEDURE

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

CARS - conservative group

Diagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria.

Group Type EXPERIMENTAL

Dental treatment

Intervention Type PROCEDURE

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

Interventions

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Dental treatment

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

Intervention Type PROCEDURE

Dental treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes