Clinical trial NCT04666597: Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
Official title: CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries in Children
Keywords: Dental caries
Children
COVID-19
Dental care
Conservative care
Aerosols
Remote consultation
Outcome assessment
Multicenter study
Lead sponsor: Universidad El Bosque, Bogotá
Sponsor class: OTHER
Collaborators: name: King's College London
name: University of Leeds
name: University of Sheffield
First posted: 2020-12-14
Enrollment: 409
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from the University Dental clinics, dental health providers and dental private practice across 21 multi-centre sites. The parents/caregivers of patients, aged 3 to 5 years and 6 to 8 years will be invited by the dentist to participate in the study and that their children are eligible to be considered for recruitment.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
timeFrame: up to 12 months
Secondary outcomes:
measure: Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
timeFrame: up to 12 months
measure: Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant.
timeFrame: up to 12 months
measure: Proportion of parents and dentists with high dental care process acceptability (measured with TEI).
timeFrame: up to 12 months
measure: Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant
timeFrame: up to 12 months
measure: Proportion of children improving oral-health related behaviours
timeFrame: up to 12 months
measure: Description of dental care costs
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Buenos Aires
country: Argentina
facility: Universidad de Buenos Aires
city: Córdoba
country: Argentina
facility: Universidad Nacional de Córdoba
city: São Paulo
country: Brazil
facility: University of Sao Paulo
city: Bogotá
country: Colombia
facility: Universidad El Bosque
state: Bogotá DC
city: Barranquilla
country: Colombia
facility: Viva 1A IPS Health Provider
city: Bogotá
country: Colombia
facility: Fundación Universitaria de Colegios de Colombia
city: Cartagena
country: Colombia
facility: Corporación Universitaria Rafael Núñez
city: Cartagena
country: Colombia
facility: Universidad de Cartagena
city: Manizales
country: Colombia
facility: ACFF Colombian Chapter Manizales Demonstration Territory
city: Medellín
country: Colombia
facility: Universidad Cooperativa de Colombia
city: Santo Domingo
country: Dominican Republic
facility: Universidad Iberoamericamericana
city: Nice
country: France
facility: Universite Cote d' Azur
city: Guadalajara
country: Mexico
facility: Universidad de Guadalajara
city: Amsterdam
country: Netherlands
facility: ACTA
city: Lima
country: Peru
facility: Universidad Peruana Cayetano Heredia
city: Porto
country: Portugal
facility: University of Porto
city: Moscow
country: Russian Federation
facility: University of Moscow
city: Sheffield
country: United Kingdom
facility: University of Sheffield
city: Buenos aires
country: Uruguay
facility: Universidad Católica de Uruguay
state: Sanmartin
Study officials:
affiliation: Universidad El Bosque
name: Stefania Martignon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Lara JS, Manton D, Martinez-Mier EA, Melo P, Muller-Bolla M, Ochoa E, Osorio JR, Ramos K, Sanabria AF, Sanjuan J, San-Martin M, Squassi A, Velasco AK, Villena R, Zandona AF, Beltran EO. CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol. BMC Oral Health. 2021 Jul 1;21(1):329. doi: 10.1186/s12903-021-01674-1.