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Evaluation of patient-centered outcomes after non-instrumentation endodontic treatment of primary molars - a multicenter randomized clinical trial with 24 months of follow-up

Grant number: 23/18210-3
Support Opportunities:Scholarships in Brazil - Master
Start date: August 01, 2024
End date: July 31, 2026
Field of knowledge:Health Sciences - Dentistry - Pediatric Dentistry
Principal Investigator:Fausto Medeiros Mendes
Grantee:Gustavo da Costa Fernandes
Host Institution: Faculdade de Odontologia (FO). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

The present study aims to analyze the patient-centered outcomes in a multicenter randomized clinical trial conducted to compare the non-instrumentation endodontic treatment technique with a conventional technique with root canal instrumentation after two years of follow-up. For this, 200 hundred children with endodontic treatment needed in a primary molar will be randomly allocated to a group that will receive a non-instrumentation technique and use of an endodontic paste containing chloramphenicol, tetracycline, zinc oxide and eugenol (CTZ paste) or to another group that will receive root canal instrumentation and use of zinc oxide and eugenol paste as filling material (ZOE group). The primary endpoint will be the clinical and radiographic success after two years. In the present study, we will focus on the secondary patient-centered outcomes. The outcomes for the present study will be clinical time spent for the endodontic treatment, anxiety and children behavior during the procedure, evaluated with Facial Image Scale e Frankl Scale, respectively, post-operative pain or edema, and short- and long-term impact of the treatment on Children's Oral Health-related quality of life reported by children and their parents, using the Child Perception Questionnaire 8-10 and Early Childhood Oral Health Impact Scale, respectively, applied one week and two years after the treatment. Two-tailed statistical analyses will be conducted for these secondary outcomes.

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