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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
- Discomfort [ Time Frame: 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 [ 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).
- 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.
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
|University of Sao Paulo|
|Sao Paulo, Brazil, 05508000|
|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|