Impact of Two Recall Intervals on Dental Caries Incidence and Other Outcomes of Preschool Children

Not Applicable

• Conditions: Dental Caries; Quality of Life; Anxiety
• Interventions: Procedure: Oral Clinical conditions

• Registration Number: NCT02537184
• Lead Sponsor: University of Sao Paulo

Brief Summary

Objectives: To assess the beneficial and harmful effects of two recall intervals on caries incidence (primary outcome) in preschool children with high 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 high caries risk according to the clinical criteria adapted from the Municipal Health Secretary of São Paulo. Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical examination + orientation for oral health and diet in return for 4 months; and Group 2 (G2) - oral clinical examination + orientation for oral health and diet in return for 8 months. An examiner calibrated and blinded to the study groups and the secondary outcomes will perform the clinical examinations, which consist of: 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, the time and costs. All groups will be followed for an initial period of 16 months, totaling four follow-up visits for G1 and two follow-up visits to the G2. All analyzes will be performed by intention to treat (ITT) and considering the sensitivity analysis to assess the differences between the ITT analyzes and analyzes of complete cases.

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 Timeline

• Study Start: 2014-09
• Status Verified: 2015-08
• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-01
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-03
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 224

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 - Recall Interval of 8 months	Oral Clinical conditions	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
Group 1 - Recall Interval of 4 months	Oral Clinical conditions	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

Primary Outcome Measures

Name	Time	Method
Dental caries incidence	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).

Secondary Outcome Measures

Name	Time	Method
Oral health related quality of life	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).
Level of anxiety	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)
Time	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.
Costs	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.

Trial Locations

Locations (1)

Dental School of University of São Paulo; 🇧🇷 São Paulo, Brazil