Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
NCT ID: NCT04666597
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
409 participants
OBSERVATIONAL
2020-11-15
2021-12-30
Brief Summary
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The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS.
The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of:
* Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children.
* Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire.
* Costs of CCI adapted for caries management, in economic terms, number and appointment time.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Adapted-CCI single-intervention group in children
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 (three 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.
Modified CariesCare International management
Interventions of this single-group study correspond to the 4D, to be implemented by the external DP, when possible with remote care and only with non-AGP:
1. D-DETERMINE risk assessing the protective and risk factors (social/medical/behavioural and clinical), using remote tools. Additionally, the description of tooth brushing behaviours and consumption of free sugars is included.
2. D-DETECT \& ASSESS: Caries staging and activity: ICDAS-merged visual criteria Caries OUT (without using compressed air, and avoiding radiographs). Clinical risk factors are assessed as well.
3. D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches.
4. D-DO: Appropriate Tooth-preserving \& Patient-level caries: Management plan at the Patient and at the Lesion level and the implementation of the Change Behaviour Tool (CBT) designed for this protocol.
The follow-up data will include a T1, T2 and T3 assessment.
Interventions
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Modified CariesCare International management
Interventions of this single-group study correspond to the 4D, to be implemented by the external DP, when possible with remote care and only with non-AGP:
1. D-DETERMINE risk assessing the protective and risk factors (social/medical/behavioural and clinical), using remote tools. Additionally, the description of tooth brushing behaviours and consumption of free sugars is included.
2. D-DETECT \& ASSESS: Caries staging and activity: ICDAS-merged visual criteria Caries OUT (without using compressed air, and avoiding radiographs). Clinical risk factors are assessed as well.
3. D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches.
4. D-DO: Appropriate Tooth-preserving \& Patient-level caries: Management plan at the Patient and at the Lesion level and the implementation of the Change Behaviour Tool (CBT) designed for this protocol.
The follow-up data will include a T1, T2 and T3 assessment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Oral-health related systemic conditions or physical/mental disabilities
* Presence of orthodontic/orthopaedic appliances
* Presence of MIH in first permanent molars with indication of extraction
* Children attending for a dental emergency/urgency
3 Years
8 Years
ALL
Yes
Sponsors
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University of Leeds
OTHER
University of Sheffield
OTHER
King's College London
OTHER
Universidad El Bosque, Bogotá
OTHER
Responsible Party
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Stefania Martignon
Principal Investigator
Principal Investigators
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Stefania Martignon, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad El Bosque
Locations
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Indiana University
Indianapolis, Indiana, United States
Tufts University
Boston, Massachusetts, United States
Universidad de Buenos Aires
Buenos Aires, , Argentina
Universidad Nacional de Córdoba
Córdoba, , Argentina
University of Sao Paulo
São Paulo, , Brazil
Universidad El Bosque
Bogotá, Bogotá DC, Colombia
Viva 1A IPS Health Provider
Barranquilla, , Colombia
Fundación Universitaria de Colegios de Colombia
Bogotá, , Colombia
Corporación Universitaria Rafael Núñez
Cartagena, , Colombia
Universidad de Cartagena
Cartagena, , Colombia
ACFF Colombian Chapter Manizales Demonstration Territory
Manizales, , Colombia
Universidad Cooperativa de Colombia
Medellín, , Colombia
Universidad Iberoamericamericana
Santo Domingo, , Dominican Republic
Universite Cote d' Azur
Nice, , France
Universidad de Guadalajara
Guadalajara, , Mexico
ACTA
Amsterdam, , Netherlands
Universidad Peruana Cayetano Heredia
Lima, , Peru
University of Porto
Porto, , Portugal
University of Moscow
Moscow, , Russia
University of Sheffield
Sheffield, , United Kingdom
Universidad Católica de Uruguay
Buenos Aires, Sanmartin, Uruguay
Countries
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References
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Martignon S, Cortes A, Douglas GVA, Newton JT, Pitts NB, Avila V, Usuga-Vacca M, Gamboa LF, Deery C, Abreu-Placeres N, Bonifacio C, Braga MM, Carletto-Korber F, Castro P, P Cerezo M, Chavarria N, Cifuentes OL, Echeverri B, Jacome-Lievano S, Kuzmina I, Lara JS, Manton D, Martinez-Mier EA, Melo P, Muller-Bolla M, Ochoa E, Osorio JR, Ramos K, Sanabria AF, Sanjuan J, San-Martin M, Squassi A, Velasco AK, Villena R, Zandona AF, Beltran EO. CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol. BMC Oral Health. 2021 Jul 1;21(1):329. doi: 10.1186/s12903-021-01674-1.
Other Identifiers
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IRB00010617
Identifier Type: -
Identifier Source: org_study_id