Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children

NCT ID: NCT02537184

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Dental Caries; Quality of Life; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1 - Recall Interval of 4 months

Oral clinical conditions:

Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Group Type: OTHER

Oral Clinical conditions

Intervention Type: PROCEDURE

caries incidence assessment dental anxiety assessment

Group 2 - Recall Interval of 8 months

Oral clinical conditions:

Only at baseline all childrens will receive 5% sodium FV (Duraphat, Colgate Oral Pharmaceuticals). Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment Procedure/Surgery: Oral clinical conditions Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Group Type: OTHER

Oral Clinical conditions

Intervention Type: PROCEDURE

caries incidence assessment dental anxiety assessment

Interventions

Oral Clinical conditions

caries incidence assessment dental anxiety assessment

Intervention Type: PROCEDURE

Other Intervention Names

Caries Incidence; dental anxiety; oral health related quality of life; time and costs

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Thais Cordeschi

MSc student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcelo Bonecker, Professor

Role: STUDY_CHAIR

University of Sao Paulo

Locations

Dental School of University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

2014/17758-6

Identifier Type: -

Identifier Source: org_study_id