Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Observational

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.
    

Intervention name(s): Modified CariesCare International management
Intervention type(s): Procedure
Intervention description(s): Interventions of this single-group study correspond to the 4D, to be implemented by the external DP, when possible with remote care and only with non-AGP:
D-DETERMINE risk assessing the protective and risk factors (social/medical/behavioural and clinical), using remote tools. Additionally, the description of tooth brushing behaviours and consumption of free sugars is included.
D-DETECT & ASSESS: Caries staging and activity: ICDAS-merged visual criteria Caries OUT (without using compressed air, and avoiding radiographs). Clinical risk factors are assessed as well.
D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches.
D-DO: Appropriate Tooth-preserving & Patient-level caries: Management plan at the Patient and at the Lesion level and the implementation of the Change Behaviour Tool (CBT) designed for this protocol.
The follow-up data will include a T1, T2 and T3 assessment.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be enrolled from the University Dental clinics, dental health providers
        and dental private practice across 21 multi-centre sites. The parents/caregivers of
        patients, aged 3 to 5 years and 6 to 8 years will be invited by the dentist to participate
        in the study and that their children are eligible to be considered for recruitment.
      
Keywords: Dental caries; Children; COVID-19; Dental care; Conservative care; Aerosols; Remote consultation; Outcome assessment; Multicenter study