Abstract
BackgroundThe assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations. There is a diversity of clinical criteria available to assess the caries lesions, resulting in differences in the dentists’ diagnosis and treatment decisions. In addition, there is a lack of evidence regarding the best criteria to detect caries lesions around the restorations. Thus, the present protocol aims to evaluate the effect of using 2 visual criteria to assess restored teeth on the outcomes related to oral health in adults.MethodsThe design protocol of the Caries Cognition and Identification in Adults trial correspond to a triple-blind randomized, controlled clinical trial with parallel-groups. Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI (World Dental Federation) criteria—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” criteria defined by the International Caries Classification and Management System (ICCMS group). The participants will be followed up after 6, 12, 18, 24, and 60 months, and the restoration failure will be the primary outcome. The analysis will be conducted through Cox regression with shared frailty. The impact of oral health on quality of life and the cost-effectiveness of the methods used will be the secondary outcomes. Two-tailed analyzes will be used, considering a level of significance of 5%.DiscussionThis is the first clinical trial to assess the effect of using two visual methods to detect caries lesions around restorations on the outcomes related to oral health in adults. The findings of this study will define what is the best diagnostic strategy for the assessment of caries around restorations in permanent teeth.Trial registration NCT03108586 (registered 11 April 2017).
Highlights
The assessment of restored teeth in dentistry remains a challenge, mainly related to the detection of caries around restorations
Two groups will be compared: patients who will receive the diagnosis and treatment decision according to FDI criteria [12]—FDI group; and patients who will receive diagnosis and treatment decision according to the “Caries Associated with Restorations or Sealants” (CARS) criteria from International Caries Classification and Management System (ICCMS) [13]—ICCMS group
The main point of debate is the detection of caries around restorations
Summary
Trial design This is a triple-blind randomized, controlled, parallelgroup clinical trial. Phase II was completed at the clinic; both examiner and gold standard examined a total of 20 patients, attributing the diagnosis and treatment according to FDI and CARS for each case. Dental treatment protocols The restorations, will be submitted to the proposed treatment according to the first evaluation performed. The study participants will be examined, classified according to predetermined criteria determined by the randomization stratified by blocks, and referred to the examiner to evaluate the restorations. Blinding The patients, care providers responsible for the dental treatment (undergraduate students and graduate students), and the assessor who will evaluate the outcomes will be blind to the participants’ allocation group. Management, and analysis The follow-up assessments will be performed by a precalibrated examiner, who does not have previous contact with the patient and with last information about the allocation groups and treatments performed. Dissemination policy The findings will be reported in full through national and international journals, patient newsletters, and websites
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
