Caries Cognition and Identification in Adults

NCT03108586 | Active Not Recruiting

• 1 other identifier: UFPEL- PPGO 0020
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

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.

Conditions

Secondary Caries

Keywords

restorations; diagnosis; secondary caries; treatment decision

Outcome Measures

Primary Outcomes (1)

• Change from baseline in number of surfaces restored requiring new intervention

  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 Outcomes (2)

• 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

Study Arms (2)

FDI - tradional group

ACTIVE COMPARATOR

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

Procedure: Dental treatment

CARS - conservative group

EXPERIMENTAL

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

Procedure: Dental treatment

Interventions

Dental treatment PROCEDURE

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

FDI - tradional group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (2)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

School of Dentistry - Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

Related Publications (3)

• Signori C, Moro BLP, Uehara JLS, Romero VHD, de Oliveira EF, Braga MM, Mendes FM, Cenci MS; CaCIA Collaborative Group. Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial. BMC Oral Health. 2020 Nov 10;20(1):317. doi: 10.1186/s12903-020-01307-z.

  PMID: 33172449 BACKGROUND

• Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

  PMID: 20628774 RESULT

• Brouwer F, Askar H, Paris S, Schwendicke F. Detecting Secondary Caries Lesions: A Systematic Review and Meta-analysis. J Dent Res. 2016 Feb;95(2):143-51. doi: 10.1177/0022034515611041. Epub 2015 Oct 13.

  PMID: 26464398 RESULT

MeSH Terms

Conditions

Disease

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Maximiliano Cenci, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 11, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2022
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)