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

NCT02263768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-04-18

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Quality of Life
  • Anxiety

Interventions

PROCEDURE

Oral clinical conditions

Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Marcelo Bönecker, Professor · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02263768 on ClinicalTrials.gov