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Completed

NCT Number: NCT02263768

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

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.

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Key information

Conditions

Dental Caries Anxiety Anxiety Disorders Mental Disorders Quality of Life Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental School of University of São Paulo

São Paulo, 05508-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral clinical conditions

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2014
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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