Clinical trial NCT02537184: Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
Official title: Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With High Caries Risk: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Quality of Life
Anxiety
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 224
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: To assess the beneficial and harmful effects of two recall intervals on caries incidence (primary outcome) in preschool children with high 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 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 calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: 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, the time and costs. All groups will be followed for an initial period of 16 months, totaling four follow-up visits for G1 and two 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 of complete cases.

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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Children between 3-5 years of age, of both genders, with caries high risk according to the clinical criteria adapted from the Secretary of Health of São Paulo and enrolled in public schools.
* Guardians who have signed the informed consent confirming their participation and their child in research.

Exclusion Criteria:

* Children showing visible dental plaque and gingivitis in baseline.
* Children showing more than 06 active and/or inactive caries cavitated surfaces, and who show fistula and/or dental abscess.
* Special patients.
* Children who received professional application of fluoride in the 6 months prior to the

Primary outcomes:
measure: Dental caries incidence
timeFrame: Baseline, 4 months and 8 months
Secondary outcomes:
measure: Level of anxiety
timeFrame: Baseline, 4 months and 8 months
measure: Oral health related quality of life
timeFrame: Baseline, 4 months and 8 months
measure: Time
timeFrame: Baseline, 4 months and 8 months
measure: Costs
timeFrame: Baseline, 4 months and 8 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dental School of University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Marcelo Bonecker, Professor
role: STUDY_CHAIR
References: