Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
Primary Purpose
Dental Caries, Quality of Life, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oral clinical conditions
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Dental School of University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group 1 - Recall Interval of 12 months
Group 2 - Recall Interval of 18 months
Arm Description
Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Oral clinical conditions: Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Level of anxiety - Change
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).
Oral health related quality of life - Change
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).
Time
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.
Costs
Costs in real (continuous variable) will be recorded in two 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.
Full Information
NCT ID
NCT02263768
First Posted
September 3, 2014
Last Updated
April 17, 2019
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02263768
Brief Title
Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
Official Title
Impact of Two Recall Intervals Associated to Oral Health Counseling on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children With Low and Moderate Caries Risk: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Quality of Life, Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Recall Interval of 12 months
Arm Type
Other
Arm Description
Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Arm Title
Group 2 - Recall Interval of 18 months
Arm Type
Other
Arm Description
Oral clinical conditions:
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Intervention Type
Procedure
Intervention Name(s)
Oral clinical conditions
Other Intervention Name(s)
Caries incidence, dental anxiety, oral health related quality of life, time and costs
Intervention Description
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Primary Outcome Measure Information:
Title
Dental caries incidence - Change
Description
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).
Time Frame
Baseline, 12 months and 18 months
Secondary Outcome Measure Information:
Title
Level of anxiety - Change
Description
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).
Time Frame
Baseline, 12 months and 18 months
Title
Oral health related quality of life - Change
Description
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).
Time Frame
Baseline, 12 months and 18 months
Title
Time
Description
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.
Time Frame
Baseline, 12 months and 18 months
Title
Costs
Description
Costs in real (continuous variable) will be recorded in two 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.
Time Frame
Baseline, 12 months and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Bönecker, Professor
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Dental School of University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
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