Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

NCT04666597 | Completed DMC

• 1 other identifier: IRB00010617
• Study Type: observational
• Target: 409
• Locations: 13 countries
• Sites: 21

Brief Summary

The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients. 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.

Conditions

Dental Caries in Children

Keywords

Dental caries; Children; COVID-19; Dental care; Conservative care; Aerosols; Remote consultation; Outcome assessment; Multicenter study

Outcome Measures

Primary Outcomes (1)

• Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)

  With the implementation of the CCI 4D-cycle adapted for the COVID-19 pandemic characterized by the patient-centred risk -based caries management systems, the the primary outcomes consist of: At the tooth surface level in avoidance of individuals and average number of surfaces with caries progression. At the individual level consist in avoidance of caries risk level increase/no control, plaque control, and avoidance of extraction, pain, failure of the restoration. Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.

  up to 12 months

Secondary Outcomes (6)

• Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)

  up to 12 months

• Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant.

  up to 12 months

• Proportion of parents and dentists with high dental care process acceptability (measured with TEI).

  up to 12 months

• Proportion of subjects with avoidance of caries risk level increase/no control, and avoidance of extraction, pain, failure of the filling/sealant

  up to 12 months

• Proportion of children improving oral-health related behaviours

  up to 12 months

Study Arms (1)

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.

Procedure: Modified CariesCare International management

Interventions

Modified CariesCare International management PROCEDURE

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.

Adapted-CCI single-intervention group in children

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be enrolled from the University Dental clinics, dental health providers and dental private practice across 21 multi-centre sites. The parents/caregivers of patients, aged 3 to 5 years and 6 to 8 years will be invited by the dentist to participate in the study and that their children are eligible to be considered for recruitment.

You may qualify if:

• Children 3 to 5 and 6 to 8 years of age.

You may not qualify if:

• Family plans to move during the study time
• 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

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead
• King's College London: collaborator
• University of Leeds: collaborator
• University of Sheffield: collaborator

Study Sites (21)

Indiana University

Indianapolis, Indiana, 47405, United States

Location

Tufts University

Boston, Massachusetts, 02155, United States

Location

Universidad de Buenos Aires

Buenos Aires, Argentina

Location

Universidad Nacional de Córdoba

Córdoba, Argentina

Location

University of Sao Paulo

São Paulo, Brazil

Location

Universidad El Bosque

Bogotá, Bogotá DC, 110121, Colombia

Location

Viva 1A IPS Health Provider

Barranquilla, Colombia

Location

Fundación Universitaria de Colegios de Colombia

Bogotá, Colombia

Location

Corporación Universitaria Rafael Núñez

Cartagena, Colombia

Location

Universidad de Cartagena

Cartagena, Colombia

Location

ACFF Colombian Chapter Manizales Demonstration Territory

Manizales, Colombia

Location

Universidad Cooperativa de Colombia

Medellín, Colombia

Location

Universidad Iberoamericamericana

Santo Domingo, Dominican Republic

Location

Universite Cote d' Azur

Nice, France

Location

Universidad de Guadalajara

Guadalajara, Mexico

Location

ACTA

Amsterdam, Netherlands

Location

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

University of Porto

Porto, Portugal

Location

University of Moscow

Moscow, Russia

Location

University of Sheffield

Sheffield, United Kingdom

Location

Universidad Católica de Uruguay

Buenos Aires, Sanmartin, Uruguay

Location

Related Publications (1)

• 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.

  PMID: 34210281 RESULT

MeSH Terms

Conditions

Dental Caries; COVID-19

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stefania Martignon, PhD

  Universidad El Bosque

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: November 15, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: CariesCare International adapted for the pandemic in children: Caries OUT multicentre single-group interventional study protocol

Locations

DO (1); FR (1); PE (1); RU (1); GB (1); PT (1); UR (1); NL (1); US (2); BR (1); CO (7); ME (1); AR (2)