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

University of Sao Paulo

Status: Completed

Conditions: Dental Caries; Quality of Life; Anxiety

Treatments: Procedure: Oral clinical conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT02263768

7709191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• 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 08 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 survey.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

Group 1 - Recall Interval of 12 months

Other group

Description:

Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Treatment:

Procedure: Oral clinical conditions

Group 2 - Recall Interval of 18 months

Other group

Description:

Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Treatment:

Procedure: Oral clinical conditions