Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666597
• Other study ID #: IRB00010617
• Status: Completed
• Start date: November 15, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2023
• Source: Universidad El Bosque, Bogotá
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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: 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.

Locations

Country	Name	City	State
Argentina	Universidad de Buenos Aires	Buenos Aires
Argentina	Universidad Nacional de Córdoba	Córdoba
Brazil	University of Sao Paulo	São Paulo
Colombia	Viva 1A IPS Health Provider	Barranquilla
Colombia	Fundación Universitaria de Colegios de Colombia	Bogotá
Colombia	Universidad El Bosque	Bogotá	Bogotá DC
Colombia	Corporación Universitaria Rafael Núñez	Cartagena
Colombia	Universidad de Cartagena	Cartagena
Colombia	ACFF Colombian Chapter Manizales Demonstration Territory	Manizales
Colombia	Universidad Cooperativa de Colombia	Medellín
Dominican Republic	Universidad Iberoamericamericana	Santo Domingo
France	Universite Cote d' Azur	Nice
Mexico	Universidad de Guadalajara	Guadalajara
Netherlands	ACTA	Amsterdam
Peru	Universidad Peruana Cayetano Heredia	Lima
Portugal	University of Porto	Porto
Russian Federation	University of Moscow	Moscow
United Kingdom	University of Sheffield	Sheffield
United States	Tufts University	Boston	Massachusetts
United States	Indiana University	Indianapolis	Indiana
Uruguay	Universidad Católica de Uruguay	Buenos aires	Sanmartin

Sponsors (4)

Lead Sponsor	Collaborator
Universidad El Bosque, Bogotá	King's College London, University of Leeds, University of Sheffield

Countries where clinical trial is conducted

United States,  Uruguay,  Argentina,  Brazil,  Colombia,  Dominican Republic,  France,  Mexico,  Netherlands,  Peru,  Portugal,  Russian Federation,  United Kingdom, 

References & Publications (1)

Martignon S, Cortes A, Douglas GVA, Newton JT, Pitts NB, Avila V, Usuga-Vacca M, Gamboa LF, Deery C, Abreu-Placeres N, Bonifacio C, Braga MM, Carletto-Korber F, Castro P, P Cerezo M, Chavarria N, Cifuentes OL, Echeverri B, Jacome-Lievano S, Kuzmina I, Lar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)	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.	up to 12 months
Secondary	Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)	Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.	up to 12 months
Secondary	Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant.	Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.	up to 12 months
Secondary	Proportion of parents and dentists with high dental care process acceptability (measured with TEI).	Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.	up to 12 months
Secondary	Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant	Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.	up to 12 months
Secondary	Proportion of children improving oral-health related behaviours	Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.	up to 12 months
Secondary	Description of dental care costs	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).	up to 12 months