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Trial record 31 of 1215 for:    tooth decay

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

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ClinicalTrials.gov Identifier: NCT02263768
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Gabriela Oliveira Berti, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE September 3, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Dental caries incidence - Change [ Time Frame: Baseline, 12 months and 18 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02263768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2015)
  • Level of anxiety - Change [ Time Frame: Baseline, 12 months and 18 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).
  • Oral health related quality of life - Change [ Time Frame: Baseline, 12 months and 18 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).
  • Time [ Time Frame: Baseline, 12 months and 18 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.
  • Costs [ Time Frame: Baseline, 12 months and 18 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
  • Level of anxiety - Change [ Time Frame: Baseline, 12 months and 18 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).
  • Oral health related quality of life - Change [ Time Frame: Baseline, 12 months and 18 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).
  • Time [ Time Frame: Baseline, 12 months and 18 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.
  • Costs [ Time Frame: Baseline, 12 months and 18 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, and costs of transportation expenses spent by the participants of the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Dental Caries
  • Quality of Life
  • Anxiety
Intervention  ICMJE Procedure: Oral clinical conditions
Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Other Names:
  • Caries incidence
  • dental anxiety
  • oral health related quality of life
  • time and costs
Study Arms  ICMJE
  • Group 1 - Recall Interval of 12 months

    Oral clinical conditions:

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

    Intervention: Procedure: Oral clinical conditions
  • Group 2 - Recall Interval of 18 months

    Oral clinical conditions:

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

    Intervention: Procedure: Oral clinical conditions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2014)
224
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02263768
Other Study ID Numbers  ICMJE 7709191
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gabriela Oliveira Berti, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marcelo Bönecker, Professor University of São Paulo
PRS Account University of Sao Paulo
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP