NCT02263768

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 18, 2019

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

September 3, 2014

Last Update Submit

April 17, 2019

Conditions

Dental CariesQuality of LifeAnxiety

Outcome Measures

Primary Outcomes (1)

  • Dental caries incidence - Change

    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, 12 months and 18 months

Secondary Outcomes (4)

  • Level of anxiety - Change

    Baseline, 12 months and 18 months

  • Oral health related quality of life - Change

    Baseline, 12 months and 18 months

  • Time

    Baseline, 12 months and 18 months

  • Costs

    Baseline, 12 months and 18 months

Study Arms (2)

Group 1 - Recall Interval of 12 months

OTHER

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 18 months

OTHER

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 conditionsPROCEDURE

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

Also known as: Caries incidence, dental anxiety, oral health related quality of life, time and costs
Group 1 - Recall Interval of 12 monthsGroup 2 - Recall Interval of 18 months

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental School of University of São Paulo

São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Dental CariesAnxiety Disorders

Interventions

Quality of LifeTimeCosts and Cost Analysis

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthPhysical PhenomenaEconomicsHealth Care Economics and Organizations

Study Officials

  • Marcelo Bönecker, 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
PhD student

Study Record Dates

First Submitted

September 3, 2014

First Posted

October 13, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 18, 2019

Record last verified: 2017-06

Locations

BR(1)