Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: All caries lesions detection (+activity assessment); Other: Advanced caries lesions detection (no activity assessment)

• Registration Number: NCT02473107
• Lead Sponsor: University of Sao Paulo

Brief Summary

The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Study Start: 2015-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-26
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Individuals aged 36 months to 83 months;
• Should have complete primary dentition;
• Children must assent to participate and their parents must consent to their participation by signing the consent form.

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Exclusion Criteria

• Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
• Children involved in other research that may impact on this study;
• Families who are expected to move out of the coverage area of study during the first year of enrollment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Caries Detection Strategy	All caries lesions detection (+activity assessment)	Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment)
Control Caries Detection Strategy	Advanced caries lesions detection (no activity assessment)	Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment)

Primary Outcome Measures

Name	Time	Method
Incremental number of dental surfaces with operative treatment needs	After 12 and 24 months from allocation	This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the initial treatment.

Secondary Outcome Measures

Name	Time	Method
Cost-efficacy	After 12 and 24 months from the allocation	The costs of the diagnostic strategy will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization.
Discomfort	immediately after the allocation and after 12 and 24 months	Participants' discomfort, measured by a validated scale (Wong-Baker scale).
Impact of oral health on quality of life	12 and 24 months after the allocation	Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS).

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil