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Caries Cognition and Identification in Adults (CaCIA)

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ClinicalTrials.gov Identifier: NCT03108586
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, 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.

Condition or disease Intervention/treatment Phase
Secondary Caries Procedure: Dental treatment Not Applicable

Detailed Description:
The study will consist of a randomized controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to FDI criteria (control group). And the other group will receive a diagnosis and treatment decision according to the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - experimental group). Patient evaluations will be performed after 12 and 24 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be: impact of oral health on quality of life and cost-effectiveness.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Caries Associated With Restorations or Sialants Cognition and Identification in Adults
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: FDI
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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108586


Contacts
Contact: Maximiliano Cenci, PhD cencims@gmail.com

Locations
Brazil
Federal University of Pelotas Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96015560
Contact: Maximiliano Cenci, PhD       cencims@gmail.com   
School of Dentistry - Federal University of Pelotas Recruiting
Pelotas, RS, Brazil, 96015560
Contact: Maximiliano S Cenci, PhD    +55 53 32226690 ext 134    cencims@gmail.com   
Sponsors and Collaborators
Federal University of Pelotas
Investigators
Principal Investigator: Maximiliano Cenci, PhD Federal University of Pelotas

Publications of Results:
Responsible Party: Maximiliano Sergio Cenci, PhD, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT03108586     History of Changes
Other Study ID Numbers: UFPEL- PPGO 0020
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maximiliano Sergio Cenci, Federal University of Pelotas:
restorations
diagnosis
secondary caries
treatment decision