Journal Article
CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol
Martignon, S.
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Cortes, A.
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Douglas, G.
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Newton, J. T.
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Pitts, N. B.
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Ávila, V.
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Usuga-Vacca, M.
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Gamboa, L. F.
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Deery, C.
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Abreu-Placeres, Ninoska
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Bonifacio, C.
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Braga, M. M.
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Carletto-Körber, F.
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Castro, P.
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Cerezo, M. P.
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Chavarría, N.
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Cifuentes, O. L.
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Echeverri, B.
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Jácome-Liévano, S.
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Kuzmina, I.
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Lara, J. S.
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Manton, D.
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Martínez-Mier, E. A.
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Melo, P.
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Muller-Bolla, M.
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Ochoa, E. M.
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Osorio, J. R.
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Ramos, K.
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Sanabria, A. F.
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Sanjuán, J.
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San-Martín, M.
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Squassi, A.
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Velasco, A. K.
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Villena, R.
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Zandona, A. F.
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Beltrán, E. O.
| Fecha de publicación | Revista | DOI |
2021 |
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.
Información adicional
Trial registration: ClinicalTrials.gov/NCT04666597