Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Last updated: November 28, 2023
Sponsor: Universidad El Bosque, Bogotá
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Modified CariesCare International management

Clinical Study ID

NCT04666597
IRB00010617
  • Ages 3-8
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 409
Treatment Group(s): 1
Primary Treatment: Modified CariesCare International management
Phase:
Study Start date:
November 15, 2020
Estimated Completion Date:
December 30, 2021

Study 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.

Connect with a study center

  • Universidad de Buenos Aires

    Buenos Aires,
    Argentina

    Site Not Available

  • Universidad Nacional de Córdoba

    Córdoba,
    Argentina

    Site Not Available

  • University of Sao Paulo

    São Paulo,
    Brazil

    Site Not Available

  • Universidad El Bosque

    Bogotá, Bogotá DC 110121
    Colombia

    Site Not Available

  • Viva 1A IPS Health Provider

    Barranquilla,
    Colombia

    Site Not Available

  • Fundación Universitaria de Colegios de Colombia

    Bogotá,
    Colombia

    Site Not Available

  • Corporación Universitaria Rafael Núñez

    Cartagena,
    Colombia

    Site Not Available

  • Universidad de Cartagena

    Cartagena,
    Colombia

    Site Not Available

  • ACFF Colombian Chapter Manizales Demonstration Territory

    Manizales,
    Colombia

    Site Not Available

  • Universidad Cooperativa de Colombia

    Medellín,
    Colombia

    Site Not Available

  • Universidad Iberoamericamericana

    Santo Domingo,
    Dominican Republic

    Site Not Available

  • Universite Cote d' Azur

    Nice,
    France

    Site Not Available

  • Universidad de Guadalajara

    Guadalajara,
    Mexico

    Site Not Available

  • ACTA

    Amsterdam,
    Netherlands

    Site Not Available

  • Universidad Peruana Cayetano Heredia

    Lima,
    Peru

    Site Not Available

  • University of Porto

    Porto,
    Portugal

    Site Not Available

  • University of Moscow

    Moscow,
    Russian Federation

    Site Not Available

  • University of Sheffield

    Sheffield,
    United Kingdom

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 47405
    United States

    Site Not Available

  • Tufts University

    Boston, Massachusetts 02155
    United States

    Site Not Available

  • Universidad Católica de Uruguay

    Buenos aires, Sanmartin
    Uruguay

    Site Not Available

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