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Impact of two different recall intervals associated with oral health orientations on caries incidence with high-caries risk pre-schools: randomized clinical trial abstract

Grant number: 18/13257-3
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): September 01, 2018
Effective date (End): August 31, 2019
Field of knowledge:Health Sciences - Dentistry - Pediatric Dentistry
Principal researcher:Marcelo Jose Strazzeri Bönecker
Grantee:Mariana Oliveira Besseler
Home Institution: Faculdade de Odontologia (FO). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

To assess the beneficial and harmful effects of two recall intervals on caries incidence in preschool children with high caries risk. Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with high caries risk according to the clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be randomly allocated into two study groups:Group 1 (G1) - oral clinical examination + orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet in return for 8 months. An examiner trained and calibrated and blinded to the study groups The oral clinical examination will include gingival bleeding index, dental biofilm index, visible and evident biofilm index, detection of caries lesions and their activity according to the International Caries Detection and Assessment System (ICDAS) and clinical characteristics of lesions of active and inactive caries will be associated with the criteria described in the ICDAS Committee manual. The guidelines on oral health care will be carried out by the student of scientific initiation. All groups will be followed for 32 months, totaling seven follow-up visits for G1 and tree follow-up visits to the G2. All analyzes will be performed by intention to treat (ITT) and considering the sensitivity analysis to assess the differences between the ITT analyzes and analyzes per protocol.

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