- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537184
Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children
Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With High Caries Risk: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 05508-000
- Dental School of University of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 |
caries incidence assessment dental anxiety assessment
Other Names:
|
Other: 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 |
caries incidence assessment dental anxiety assessment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental caries incidence
Time Frame: Baseline, 4 months and 8 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of anxiety
Time Frame: Baseline, 4 months and 8 months
|
Level of anxiety will be assessed using the Facial Image Scale (Buchanan H, Niven N. Validation of a facial image scale to assess child dental anxiety.
Int J Paediatr Dent 2002;12:47-52)
|
Baseline, 4 months and 8 months
|
Oral health related quality of life
Time Frame: Baseline, 4 months and 8 months
|
Oral health related quality of life will be assessed using the Brazilian validation of the ECOHIS (Scarpelli AC, Oliveira BH, Tesch FC, Leão AT, Pordeus IA, Paiva SM.
Psychometric properties of the Brazilian version of the Early Childhood Oral Health Impact Scale (B-ECOHIS).
BMC Oral Health.
2011; 11:19).
|
Baseline, 4 months and 8 months
|
Time
Time Frame: Baseline, 4 months and 8 months
|
The time in minutes, used in the recall interval visits, will be recorded in four categories: time spent on clinical examination including prophylaxis, hygiene and diet orientations, and time spent when the patient miss the recall visit.
The total time will correspond to the sum of these categories.
|
Baseline, 4 months and 8 months
|
Costs
Time Frame: Baseline, 4 months and 8 months
|
Costs in real (continuous variable) will be recorded in three categories: salary of the dentist and dental assistant paid in public dental services in São Paulo, cost of dental materials/products used in the appointment.
|
Baseline, 4 months and 8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marcelo Bönecker, Professor, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/17758-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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