NCT02263768

Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children

Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

Summary

Objectives: To assess the effectiveness of two recall intervals on dental caries incidence (primary outcome) in preschool children with low and moderate caries risk. The level of anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes) according to each interval will also be assessed. Methods: The sample will consist of 224 children between 3-5 years of age, of both genders, with low and moderate caries risk according to the clinical criteria adapted from the Secretary of Health of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet on the recall of 12 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18 months.

Detailed description

An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: the gingival bleeding index, dental plaque index, detection of caries and its activity according to the ICDAS (International Caries Detection and Assessment System) and the clinical features of active and inactive caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An external dentist will conduct the assessment of the anxiety levels assessed by the Facial Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact Scale), the time and costs. All groups will be followed for a period of 36 months. All analyzes will be performed with the intention of treatment (ITT) and considering the sensitivity analyzes to assess the differences between the ITT analyzes and the complete cases analyzes.

Conditions

• Dental Caries
• Quality of Life
• Anxiety

Interventions

Type	Name	Description
PROCEDURE	Oral clinical conditions	Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2014-10-13
• Last updated: 2019-04-18

Locations

1 site across 1 country: Brazil