Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

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.

Conditions

• Dental Caries in Children

Interventions

PROCEDURE

Modified CariesCare International management

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: 1. 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. 2. 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. 3. D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches. 4. 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.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• University of Leeds

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• Universidad El Bosque, Bogotá

  lead OTHER

Principal Investigators

• Stefania Martignon, PhD · Universidad El Bosque

Eligibility

Min Age

3 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-15

Primary Completion

2021-12-30

Completion

2021-12-30

Countries

• United States
• Argentina
• Brazil
• Colombia
• Dominican Republic
• France
• Mexico
• Netherlands
• Peru
• Portugal
• Russia
• United Kingdom
• Uruguay

Study Locations