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Title: CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol
Autores: Martignon, S.
Cortes, A.
Douglas, G.
Newton, J. T.
Pitts, N. B.
Ávila, V.
Usuga-Vacca, M.
Gamboa, L. F.
Deery, C.
Abreu-Placeres, Ninoska
Bonifacio, C.
Braga, M. M.
Carletto-Körber, F.
Castro, P.
Cerezo, M. P.
Chavarría, N.
Cifuentes, O. L.
Echeverri, B.
Jácome-Liévano, S.
Kuzmina, I.
Lara, J. S.
Manton, D.
Martínez-Mier, E. A.
Melo, P.
Muller-Bolla, M.
Ochoa, E. M.
Osorio, J. R.
Ramos, K.
Sanabria, A. F.
Sanjuán, J.
San-Martín, M.
Squassi, A.
Velasco, A. K.
Villena, R.
Zandona, A. F.
Beltrán, E. O.
Researchers (UNIBE): Abreu-Placeres, Ninoska 
Affiliations: Centro de Investigación en Biomateriales y Odontología (CIBO) 
Research area: Ciencias de la Salud
Keywords: Aerosols; COVID-19; Children; Conservative care; Dental care; Dental caries; Multicenter study; Outcome assessment; Remote consultation
Issue Date: 2021
Publisher: BioMed Central Ltd.
Source: BMC Oral Health, 21(1), 1-13
Journal: BMC Oral Health 
Volume: 21
Issue: 1
Start page: 1
End page: 13
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:
Gov't Doc #: NCT04666597
DOI: 10.1186/s12903-021-01674-1
Appears in Collections:Publicaciones del CIBO-UNIBE
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