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Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

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ClinicalTrials.gov Identifier: NCT02473107
Recruitment Status : Active, not recruiting
First Posted : June 16, 2015
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Mariana Minatel Braga, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Advanced caries lesions detection (no activity assessment) Other: All caries lesions detection (+activity assessment) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth
Study Start Date : February 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Control Caries Detection Strategy
Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment)
Other: Advanced caries lesions detection (no activity assessment)
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

Test Caries Detection Strategy
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)
Other: All caries lesions detection (+activity assessment)
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473107


Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05508000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Mariana M Braga University of Sao Paulo
Principal Investigator: Isabela Floriano University of Sao Paulo
Principal Investigator: Fausto M Mendes University of Sao Paulo

Publications of Results:
Other Publications:

Responsible Party: Mariana Minatel Braga, PhD, Senior Lecturer, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02473107     History of Changes
Other Study ID Numbers: CARDEC-02
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Keywords provided by Mariana Minatel Braga, University of Sao Paulo:
Dental caries
Primary tooth
Caries Detection

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases