Martignon, Stefania http://orcid.org/0000-0002-6505-8356
Cortes, Andrea
Douglas, Gail V. A.
Newton, J. Timothy
Pitts, Nigel B.
Avila, Viviana
Usuga-Vacca, Margarita
Gamboa, Luis F.
Deery, Christopher
Abreu-Placeres, Ninoska
Bonifacio, Clarisa
Braga, Mariana M.
Carletto-Körber, Fabiana
Castro, Patricia
P. Cerezo, María
Chavarría, Nathaly
Cifuentes, Olga L.
Echeverri, Beatriz
Jácome-Liévano, Sofía
Kuzmina, Irina
Lara, J. Sebastián
Manton, David
Martínez-Mier, E. Angeles
Melo, Paulo
Muller-Bolla, Michèle
Ochoa, Emilia
Osorio, Jesús R.
Ramos, Ketty
Sanabria, Angie F.
Sanjuán, Johanna
San-Martín, Magdalena
Squassi, Aldo
Velasco, A. Karina
Villena, Rita
Zandona, Andrea Ferreira
Beltrán, Edgar O.
Clinical trials referenced in this document:
Documents that mention this clinical trial
CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol
https://0-doi-org.brum.beds.ac.uk/10.1186/s12903-021-01674-1
Funding for this research was provided by:
IADR Regional Development Program - Latin American Region
Article History
Received: 6 May 2021
Accepted: 14 June 2021
First Online: 1 July 2021
Ethics approval and consent to participate
: The Research Institutional Ethics Committee in Universidad El Bosque with the Office for Human Research Protection (OHRP) identification: IRB00010617, gave the following approval reference number to the research project, with Universidad El Bosque as leading centre: PCI 2019-10718. The corresponding written consent form (Additional file InternalRef removed) and assent form (Additional file InternalRef removed) will be signed by parents and/or children (in countries and ages that require it). A total of 21 centres, 20 dental schools and one health provider, will be included in this study: seven in Colombia (Universidad El Bosque, Corporación Universitaria Rafael Núñez, Fundación Universitaria de Colegios de Colombia UNICOC Bogotá, Universidad Autónoma de Manizales, Universidad Cooperativa de Colombia Envigado, Universidad de Cartagena, Viva 1A IPS Barranquilla), two in Argentina (Universidad de Buenos Aires, Universidad Nacional de Córdoba), two in the USA (Indiana University, Tufts University), and one each in Brazil (University of Sao Paulo), Dominican Republic (Universidad Iberoamericamericana UNIBE), France (Universite Cote d’ Azur), México (Universidad de Guadalajara), Perú (Universidad San Martín de Porres), Portugal (University of Porto), the Netherlands (ACTA), Russia (Moscow State University of Medicine and Dentistry), United Kingdom UK (The University of Sheffield), and Uruguay (Universidad Católica de Uruguay). Study organisational frame (Fig. InternalRef removed): The Study Steering Committee (SM, AC, GD, TN, NP, VA, MUV, LFG, CD, EB) is in charge of monitoring and communicating with all centres, and of general project oversight. The Coordinating Centre–CC (SM, AC, EB) is in UNICA at Universidad El Bosque and its role is helping coordinating the study from its start to its completion. The Endpoint Adjudication Committee (SM, AC, VA, EB) is in charge of managing the adjudication specific process during the whole study. The Data Management Team-DMT (SM, AC, VA, LFG, EB) is responsible for the overall data management collected from all centres. This will report to the Study Steering Committee and it is independent from the sponsor. The Local Centres Leaders’ Committee is composed by the centres’ coordinators together with the representatives of the CC (SM, AC, CD, NAP, CB, MB, FC, PC, MPC, NC, IK, JSL, EAMM, PM, MMB, EO, JRO, KR, JS, MSM, AS, RV, AFZ, EB). The assessment/reassessments and care data will be recorded by examiners and dental practitioner/s. Data will be kept anonymous. Patients will be identified by a number assigned for each patient and their care centre.
: Not applicable.
: The authors declare that they have no competing interests.