Caries Cognition and Identification in Adults (CaCIA)

April 24, 2023 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas

Caries Associated With Restorations or Sialants Cognition and Identification in Adults

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Pelotas, RS, Brazil, 96015560
        • School of Dentistry - Federal University of Pelotas
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015560
        • Federal University of Pelotas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FDI - tradional group
Diagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI).
Procedure: Dental treatment
Dental treatment of all dental needs present in adults related or not to the dental caries
Experimental: CARS - conservative group
Diagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria.
Procedure: Dental treatment
Dental treatment of all dental needs present in adults related or not to the dental caries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in number of surfaces restored requiring new intervention
Time Frame: 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.
12 months, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14)
Time Frame: 12 months, 24 months
12 months, 24 months
Cost-effectiveness measured by a scale
Time Frame: 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)
12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Pelotas

Investigators

  • Principal Investigator: Maximiliano Cenci, PhD, Federal University of Pelotas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Anticipated)

December 1, 2032

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPEL- PPGO 0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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