Portal de investigación
CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol
Fecha de publicación:
Fecha Ahead of Print:
Autores organización
Autores
- Douglas GVA
- Newton JT
- Pitts NB
- Gamboa LF
- Deery C
- Abreu-Placeres N
- Bonifacio C
- Braga MM
- Carletto-Körber F
- Castro P
- P Cerezo M
- Chavarría N
- Cifuentes OL
- Echeverri B
- Kuzmina I
- Lara JS
- Manton D
- Martínez-Mier EA
- Melo P
- Muller-Bolla M
- Ochoa E
- Osorio JR
- Ramos K
- Sanjuán J
- San-Martín M
- Squassi A
- Velasco AK
- Villena R
- Zandona AF
Grupos de investigación
Resumen
Background: Comprehensive caries care has shown effectiveness in controlling caries progression and improving health outcomes by controlling caries risk, preventing initial-caries lesions progression, and patient satisfaction. To date, the caries-progression control effectiveness of the patient-centred risk-based CariesCare International (CCI) system, derived from ICCMS™ for the practice (2019), remains unproven. With the onset of the COVID-19 pandemic a previously planned multi-centre RCT shifted to this “Caries OUT” study, aiming to assess in a single-intervention group in children, the caries-control effectiveness of CCI adapted for the pandemic with non-aerosols generating procedures (non-AGP) and reducing in-office time. Methods: In this 1-year multi-centre single-group interventional trial the adapted-CCI effectiveness will be assessed in one single group in terms of tooth-surface level caries progression control, and secondarily, individual-level caries progression control, children’s oral-health behaviour change, parents’ and dentists’ process acceptability, and costs exploration. A sample size of 258 3–5 and 6–8 years old patients was calculated after removing half from the previous RCT, allowing for a 25% dropout, including generally health children (27 per centre). The single-group intervention will be the adapted-CCI 4D-cycle caries care, with non-AGP and reduced in-office appointments’ time. A trained examiner per centre will conduct examinations at baseline, at 5–5.5 months (3 months after basic management), 8.5 and 12 months, assessing the child’s CCI caries risk and oral-health behaviour, visually staging and assessing caries-lesions severity and activity without air-drying (ICDAS-merged Epi); fillings/sealants; missing/dental-sepsis teeth, and tooth symptoms, synthetizing together with parent and external-trained dental practitioner (DP) the patient- and tooth-surface level diagnoses and personalised care plan. DP will deliver the adapted-CCI caries care. Parents’ and dentists’ process acceptability will be assessed via Treatment-Evaluation-Inventory questionnaires, and costs in terms of number of appointments and activities. Twenty-one centres in 13 countries will participate. Discussion: The results of Caries OUT adapted for the pandemic will provide clinical data that could help support shifting the caries care in children towards individualised oral-health behaviour improvement and tooth-preserving care, improving health outcomes, and explore if the caries progression can be controlled during the pandemic by conducting non-AGP and reducing in-office time. Trial registration: Retrospectively-registered-ClinicalTrials.gov-NCT04666597-07/12/2020: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000AGM4&selectaction=Edit&uid=U00019IE&ts=2&cx=uwje3h. Protocol-version 2: 27/01/2021. © 2021, The Author(s).
Datos de la publicación
- ISSN/ISSNe:
- 1472-6831, 1472-6831
- Tipo:
- Article
- Páginas:
- 329-329
- PubMed:
- 34210281
- Enlace a otro recurso:
- www.scopus.com
Bmc Oral Health BioMed Central Ltd
Citas Recibidas en Web of Science: 3
Citas Recibidas en Scopus: 6
Documentos
- No hay documentos
Filiaciones
Keywords
- Adolescent; Adult; Aged; Child; Child, Preschool; COVID-19; Dental Caries; Dental Caries Susceptibility; Dentists; Humans; Middle Aged; Multicenter Studies as Topic; Pandemics; Professional Role; Retrospective Studies; SARS-CoV-2; Young Adult; adolescent; adult; aged; child; dental caries; dentist; human; middle aged; multicenter study (topic); pandemic; preschool child; professional standard; retrospective study; young adult
Proyectos asociados
Desenlaces en Salud con CariesCare International: Estudio clínico pragmático. Título de la Enmienda al Proyecto: "Caries OUT: Estudio multicéntrico en niños con CariesCare International adaptado para la pandemia de COVID-19"
Investigador Principal: EDGAR ORLANDO BELTRAN ZUÑIGA
PCI-2019-10718 . 2020
Caracterización epidemiológica, diagnóstica y metagenómica relacionada con caries radicular en adultos mayores institucionalizados de Bogotá
Investigador Principal: STEFANIA MARTIGNON BIERMANN
UEB-2016-409 . 2016