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Completed

NCT Number: NCT02473107

Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

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.

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Key information

Age range

36 month–83 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05508000, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

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.

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.

Treatment and study plan

Advanced caries lesions detection (no activity assessment)

Other

The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.

Other names: WHO criteria, Advanced caries lesions, Extensive Decays

All caries lesions detection (+activity assessment)

Other

The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.

Other names: Caries activity assessment, initial caries lesions, early detection

Primary outcomes

  1. Incremental number of dental surfaces with operative treatment needs

    Time frame: 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 outcomes

  1. Cost-efficacy

    Time frame: 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.

  2. Discomfort

    Time frame: immediately after the allocation and after 12 and 24 months

    Participants' discomfort, measured by a validated scale (Wong-Baker scale).

  3. Impact of oral health on quality of life

    Time frame: 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).

Other outcomes

  1. Costs

    Time frame: Immediately after allocation

    The costs of each diagnostic strategy and treatment based on that will be calculated, regarding time of each clinical session, materials used, duration of treatment and possible repetitions.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2015
Registry last updated
Dec 28, 2022

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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