Stefania Martignon1, Andrea Cortes2, Gail V A Douglas3, J Timothy Newton4, Nigel B Pitts4, Viviana Avila2, Margarita Usuga-Vacca2, Luis F Gamboa2, Christopher Deery5, Ninoska Abreu-Placeres6, Clarisa Bonifacio7, Mariana M Braga8, Fabiana Carletto-Körber9, Patricia Castro10, María P Cerezo11, Nathaly Chavarría2, Olga L Cifuentes11, Beatriz Echeverri12, Sofía Jácome-Liévano2, Irina Kuzmina13, J Sebastián Lara14, David Manton15, E Angeles Martínez-Mier14, Paulo Melo16, Michèle Muller-Bolla17, Emilia Ochoa12, Jesús R Osorio18, Ketty Ramos19, Angie F Sanabria2, Johanna Sanjuán20, Magdalena San-Martín2,21, Aldo Squassi22, A Karina Velasco2, Rita Villena23, Andrea Ferreira Zandona24, Edgar O Beltrán2. 1. UNICA - Caries Research Unit, Research Department, Universidad El Bosque, Av. Cra. 9 No. 131 A - 02, 110121, Bogotá, Colombia. martignonstefania@unbosque.edu.co. 2. UNICA - Caries Research Unit, Research Department, Universidad El Bosque, Av. Cra. 9 No. 131 A - 02, 110121, Bogotá, Colombia. 3. Dental Public Health, Leeds Dental Institute, University of Leeds, Leeds, UK. 4. Dental Innovation and Impact, Faculty of Dentistry, Oral and Craniofacial Sciences, King's College London, London, UK. 5. School of Clinical Dentistry, The University of Sheffield, Sheffield, UK. 6. Biomaterials and Dentistry Research Center (CIBO-UNIBE), Academic Research Department, Universidad Iberoamericana UNIBE, Santo Domingo, Dominican Republic. 7. Department of Pediatric Dentistry, Academic Center for Dentistry Amsterdam, Amsterdam, The Netherlands. 8. Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. 9. Comprehensive Children and Adolescents Clinic, Paediatric Dentistry, Universidad Nacional de Córdoba, Córdoba, Argentina. 10. School of Dentistry, Corporación Universitaria Rafael Núñez, Cartagena, Colombia. 11. School of Dentistry, Universidad Autónoma de Manizales, Manizales, Colombia. 12. School of Dentistry, Universidad Cooperativa de Colombia, Envigado, Colombia. 13. Department of Preventive Dentistry, Moscow State University of Medicine and Dentistry, Moscow, Russia. 14. Department of Cariology, Operative Dentistry and Dental Public Health, Indiana University School of Dentistry, Indianapolis, IN, USA. 15. Centrum Voor Tandheelkunde en Mondzorgkunde, UMCG, University of Groningen, Groningen, The Netherlands. 16. EpiUnit, Faculty of Dental Medicine, Institute of Public Health, University of Porto, Porto, Portugal. 17. Department of Paediatric Dentistry, Côte D'Azur University, Nice, France. 18. Viva 1A IPS Health Provider, Barranquilla, Colombia. 19. School of Dentistry, Universidad de Cartagena, Cartagena, Colombia. 20. Paedriatric Dentistry Department, Fundación Universitaria de Colegios de Colombia (UNICOC), Bogotá, Colombia. 21. School of Dentistry, Universidad Católica de Uruguay, Montevideo, Uruguay. 22. School of Dentistry, Universidad de Buenos Aires, Buenos Aires, Argentina. 23. Paediatric Dentistry Department, Universidad San Martín de Porres, Lima, Peru. 24. Department of Comprehensive Care, School of Dental Medicine, Tufts University, Boston, MA, USA.
Abstract
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.
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.
Authors: Nigel B Pitts; Domenick T Zero; Phil D Marsh; Kim Ekstrand; Jane A Weintraub; Francisco Ramos-Gomez; Junji Tagami; Svante Twetman; Georgios Tsakos; Amid Ismail Journal: Nat Rev Dis Primers Date: 2017-05-25 Impact factor: 52.329
Authors: N P Innes; J E Clarkson; G V A Douglas; V Ryan; N Wilson; T Homer; Z Marshman; E McColl; L Vale; M Robertson; A Abouhajar; R D Holmes; R Freeman; B Chadwick; C Deery; F Wong; A Maguire Journal: J Dent Res Date: 2019-11-26 Impact factor: 6.116
Authors: Stefania Martignon; Nigel B Pitts; Guy Goffin; Marco Mazevet; Gail V A Douglas; J Tim Newton; Svante Twetman; Christopher Deery; Sophie Doméjean; Anahita Jablonski-Momeni; Avijit Banerjee; Justine Kolker; David Ricketts; Ruth M Santamaria Journal: Br Dent J Date: 2019-09 Impact factor: 1.626