NCT04666597

Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Completed Last updated 4 December 2023

What this trial tests

trial testing Modified CariesCare International management in Dental Caries in Children in 409 participants. Completed in 30 December 2021.

Timeline

15 November 2020

Primary endpoint
30 December 2021

30 December 2021

Quick facts

Lead sponsor	Universidad El Bosque, Bogotá
Status	Completed
Study type	OBSERVATIONAL
Enrollment	409
Start date	15 November 2020
Primary completion	30 December 2021
Estimated completion	30 December 2021
Sites	21 locations across France, Colombia, Netherlands, Russia, Dominican Republic, Peru, United Kingdom, Mexico

Drugs / interventions tested

• Modified CariesCare International management

Conditions studied

• Dental Caries in Children — all drugs for Dental Caries in Children →

Sponsor

Universidad El Bosque, Bogotá — full company profile →

Who can join

Adults 3 to 8, any sex, with Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol.
   Martignon S, Cortes A, Douglas GVA, Newton JT, et al · · 2021 · cited 11× · PMID 34210281 · DOI 10.1186/s12903-021-01674-1
2. How did CariesCare International performed under pandemic conditions in children: 1-year multicenter single-group interventional study
   Martignon S, Beltrán EO, Douglas GVA, Newton JT, et al · · 2024 · DOI 10.21203/rs.3.rs-3901123/v1