Impact of Detecting Initial and Active Caries Lesions in Primary Teeth

March 20, 2018 updated by: Mariana Minatel Braga, University of Sao Paulo

CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 12 and 24 months from allocation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 12 and 24 months from the allocation
Discomfort
Time Frame: immediately after the allocation and after 12 and 24 months
Participants' discomfort, measured by a validated scale (Wong-Baker scale).
immediately after the allocation and after 12 and 24 months
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).
12 and 24 months after the allocation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after allocation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

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

Investigators

  • Principal Investigator: Isabela Floriano, University of Sao Paulo
  • Principal Investigator: Fausto M Mendes, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDEC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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