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NCT Number: NCT04666597

Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

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.

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Key information

Conditions

Dental Caries in Children COVID-19 Coronaviridae Infections Coronavirus Infections Dental Caries Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases Tooth Demineralization Tooth Diseases Virus Diseases

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 3 to 5 and 6 to 8 years of age.

Exclusion criteria

  • 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

Treatment and study plan

Modified CariesCare International management

Procedure

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.

Primary outcomes

  1. Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)

    Time frame: 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 outcomes

  1. Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)

    Time frame: up to 12 months

    Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  2. Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant.

    Time frame: up to 12 months

    Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  3. Proportion of parents and dentists with high dental care process acceptability (measured with TEI).

    Time frame: up to 12 months

    Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  4. Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant

    Time frame: up to 12 months

    Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  5. Proportion of children improving oral-health related behaviours

    Time frame: up to 12 months

    Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  6. Description of dental care costs

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universidad El Bosque, Bogotá

Other

Collaborators

  • King's College London
  • University of Leeds
  • University of Sheffield

Registry information

Official study title

CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 14, 2020
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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