Clinical trial NCT03108586: Caries Cognition and Identification in Adults
Official title: Caries Associated With Restorations or Sialants Cognition and Identification in Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Secondary Caries
Keywords: restorations
diagnosis
secondary caries
treatment decision
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in number of surfaces restored requiring new intervention
timeFrame: 12 months, 24 months
Secondary outcomes:
measure: Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14)
timeFrame: 12 months, 24 months
measure: Cost-effectiveness measured by a scale
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: School of Dentistry - Federal University of Pelotas
state: RS
Study officials:
affiliation: Federal University of Pelotas
name: Maximiliano Cenci, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.