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

NCT02537184 | Unknown DMC

• 1 other identifier: 2014/17758-6
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Quality of Life; Anxiety

Outcome Measures

Primary Outcomes (1)

• Dental caries incidence

  Dental caries will be assessed using the ICDAS criteria (Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, et al. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol 2007; 35: 170-8).

  Baseline, 4 months and 8 months

Secondary Outcomes (4)

• Level of anxiety

  Baseline, 4 months and 8 months

• Oral health related quality of life

  Baseline, 4 months and 8 months

• Time

  Baseline, 4 months and 8 months

• Costs

  Baseline, 4 months and 8 months

Study Arms (2)

Group 1 - Recall Interval of 4 months

OTHER

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

Procedure: Oral Clinical conditions

Group 2 - Recall Interval of 8 months

OTHER

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

Procedure: Oral Clinical conditions

Interventions

Oral Clinical conditions PROCEDURE

caries incidence assessment dental anxiety assessment

Also known as: Caries Incidence, dental anxiety, oral health related quality of life, time and costs

Group 1 - Recall Interval of 4 months; Group 2 - Recall Interval of 8 months

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Dental School of University of São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Dental Caries; Anxiety Disorders

Interventions

Quality of Life; Time; Costs and Cost Analysis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Physical Phenomena; Economics; Health Care Economics and Organizations

Study Officials

• Marcelo Bonecker, Professor

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 3, 2015

Record last verified: 2015-08

Locations

BR (1)