Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
- Conditions
- Dental Caries in Children
- Registration Number
- NCT04666597
- Lead Sponsor
- Universidad El Bosque, Bogotá
- Brief Summary
The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients.
The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS.
The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of:
* Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children.
* Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire.
* Costs of CCI adapted for caries management, in economic terms, number and appointment time.
- Detailed Description
This study has been planned to be developed in 21 centres: 5 Colombian, 14 international dental schools, 1 Colombian health care provider and a demonstrative centre of the ACFF. Each center will implement the CCI management adapted for COVID-19 era in a total of 20 3 to 5- and 6 to 8-year-old children. Children's caries care can be delivered at dental schools' clinics and private practice. Follow-up assessments will be conducted at 3, 6 and 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 409
- Children 3 to 5 and 6 to 8 years of age.
- Family plans to move during the study time
- Oral-health related systemic conditions or physical/mental disabilities
- Presence of orthodontic/orthopaedic appliances
- Presence of MIH in first permanent molars with indication of extraction
- Children attending for a dental emergency/urgency
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity) up to 12 months With the implementation of the CCI 4D-cycle adapted for the COVID-19 pandemic characterized by the patient-centred risk -based caries management systems, the the primary outcomes consist of: At the tooth surface level in avoidance of individuals and average number of surfaces with caries progression. At the individual level consist in avoidance of caries risk level increase/no control, plaque control, and avoidance of extraction, pain, failure of the restoration. Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
- Secondary Outcome Measures
Name Time Method Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity) up to 12 months Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant. up to 12 months Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Description of dental care costs up to 12 months The providers' payment model of the centre will be described (Fee-for-service, Capitation, Salary-based and Pay-for-performance) (43). For the description of costs, these will be converted to the United States Dollar (USD) under the average Market Representative Exchange Rate for the year 2021 (MRER-average).
Proportion of children improving oral-health related behaviours up to 12 months Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Proportion of parents and dentists with high dental care process acceptability (measured with TEI). up to 12 months Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant up to 12 months Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Trial Locations
- Locations (21)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Tufts University
🇺🇸Boston, Massachusetts, United States
Universidad de Buenos Aires
🇦🇷Buenos Aires, Argentina
Universidad Nacional de Córdoba
🇦🇷Córdoba, Argentina
University of Sao Paulo
🇧🇷São Paulo, Brazil
Universidad El Bosque
🇨🇴Bogotá, Bogotá DC, Colombia
Viva 1A IPS Health Provider
🇨🇴Barranquilla, Colombia
Fundación Universitaria de Colegios de Colombia
🇨🇴Bogotá, Colombia
Corporación Universitaria Rafael Núñez
🇨🇴Cartagena, Colombia
Universidad de Cartagena
🇨🇴Cartagena, Colombia
Scroll for more (11 remaining)Indiana University🇺🇸Indianapolis, Indiana, United States