Dental Caries in ChildrenNCT04666597
Pandemic-adapted Caries Care Multicentre Single-group Interventional Study
An observational study of Dental Caries in Children, run by Universidad El Bosque, Bogotá at 21 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Modified CariesCare International management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 409 participants
- Where
- 21 sitesin 13 countries
- Study dates
- 15 Nov 2020to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Children 3 to 5 and 6 to 8 years of age.
Who cannot join
- 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
Trial locations and contacts
21 sites in 13 countries.
21 sites in 13 countries
Colombia7 sites
Viva 1A IPS Health Provider
Barranquilla
Universidad El Bosque
Bogotá, Bogotá DC, 110121
Fundación Universitaria de Colegios de Colombia
Bogotá
Corporación Universitaria Rafael Núñez
Cartagena
Universidad de Cartagena
Cartagena
ACFF Colombian Chapter Manizales Demonstration Territory
Manizales
Universidad Cooperativa de Colombia
Medellín
United States2 sites
Tufts University
Boston, Massachusetts, 02155
Indiana University
Indianapolis, Indiana, 47405
Argentina2 sites
Universidad de Buenos Aires
Buenos Aires
Universidad Nacional de Córdoba
Córdoba
Dominican Republic1 site
Universidad Iberoamericamericana
Santo Domingo
About this study
Official title: CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study
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.
Read more
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.
Read the detailed description
This study has been planned to be developed in 21 centres: 5 Colombian, 14 international dental schools, 1 Colombian health care provider and a demonstrative centre of the ACFF. Each center will implement the CCI management adapted for COVID-19 era in a total of 20 3 to 5- and 6 to 8-year-old children. Children's caries care can be delivered at dental schools' clinics and private practice. Follow-up assessments will be conducted at 3, 6 and 12 months.
- Conditions
- Dental Caries in Children
- Being tested
- Modified CariesCare International management
- Keywords
- Dental caries, Children, COVID-19, Dental care, Conservative care, Aerosols, Remote consultation, Outcome assessment, Multicenter study
- Medical subject headings
- Dental Caries, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified CariesCare International managementProcedure or surgery
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:
- 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.
- 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.
- D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Modified CariesCare International management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (6)
Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Measured: 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.
Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Measured: up to 12 months
Proportion of parents and dentists with high dental care process acceptability (measured with TEI).
Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Measured: 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
Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Measured: up to 12 months
Proportion of children improving oral-health related behaviours
Figures will be described using mean and standard deviation (SD) for quantitative variables and percentages for qualitative variables.
Measured: up to 12 months
Description of dental care costs
The providers' payment model of the centre will be described (Fee-for-service, Capitation, Salary-based and Pay-for-performance) (43). For the description of costs, these will be converted to the United States Dollar (USD) under the average Market Representative Exchange Rate for the year 2021 (MRER-average).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start15 Nov 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Leeds, University of Sheffield
- Responsible party
- Principal investigator, Stefania Martignon, Universidad El Bosque, Bogotá
- Investigators
- Stefania Martignon, PhD, Principal investigator, Universidad El Bosque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666597
- Sponsor's protocol ID
- IRB00010617
- Status last verified
- Nov 2023
- First submitted
- 7 Dec 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD
Publications
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.
PubMed 34210281
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CariesCare International Adapted for the Pandemic in Children: Caries OUT Multicentre Single-group Interventional Study
- ClinicalTrials.gov ID
- NCT04666597
- Acronym / sponsor ID
- IRB00010617
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Children, COVID-19, Dental care, Conservative care, Aerosols, Remote consultation, Outcome assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Collaborators
- King's College London, University of Leeds, University of Sheffield
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study has been planned to be developed in 21 centres: 5 Colombian, 14 international dental schools, 1 Colombian health care provider and a demonstrative centre of the ACFF. Each center will implement the CCI management adapted for COVID-19 era in a total of 20 3 to 5- and 6 to 8-year-old children. Children's caries care can be delivered at dental schools' clinics and private practice. Follow-up assessments will be conducted at 3, 6 and 12 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted-CCI single-intervention group in children | – | Procedure: Modified CariesCare International managementThe 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Children 3 to 5 and 6 to 8 years of age.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified CariesCare International managementInterventions 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. | Procedure or surgery | Adapted-CCI single-intervention group in children |
Primary outcome
Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
Time frame: up to 12 months
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.
6 secondary outcomes
Proportion of subjects with avoidance of caries progression (ICDAS-merged Epi severity and/or activity)
Time frame: 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.
Time frame: up to 12 months
Proportion of parents and dentists with high dental care process acceptability (measured with TEI).
Time frame: 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
Time frame: up to 12 months
Proportion of children improving oral-health related behaviours
Time frame: up to 12 months
Description of dental care costs
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Results publication: PubMed 34210281Martignon 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.
- Individual participant dataSharing planned: Yes. All IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Martignon, PhD principal investigator
Universidad El Bosque
21 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries in Children, run by Universidad El Bosque, Bogotá at 21 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Colombia, United States, Argentina, Brazil, Dominican Republic and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of tooth surfaces with avoidance of caries progression (ICDAS-merged Epi severity and/or activity) (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.