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NCT Number: NCT03108586

Caries 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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dental treatment

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

Caries Associated With Restorations or Sialants Cognition and Identification in Adults

Acronym: CaCIA

Important dates

Study start
2016
Primary completion
2022
Study completion
2032
First posted
Apr 11, 2017
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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