CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 409
- 试验地点
- 21
- 主要终点
- Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 3 to 5 and 6 to 8 years of age.
排除标准
- •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
结局指标
主要结局
Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
时间窗: 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.
次要结局
- Proportion of children improving oral-health related behaviours(up to 12 months)
- Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)(up to 12 months)
- 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)
- Description of dental care costs(up to 12 months)
- Proportion of parents and dentists with high dental care process acceptability (measured with TEI).(up to 12 months)
- 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)
研究者
Stefania Martignon
Principal Investigator
Universidad El Bosque, Bogotá