Dental CariesNCT02473107
Impact of Detecting Initial and Active Caries Lesions in Primary Teeth
A study testing Advanced caries lesions detection (no activity assessment) and All caries lesions detection (+activity assessment) in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. Read more about this study
- Who is it for?
- Ages 36 to 83 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Advanced caries lesions detection (no activity assessment) and All caries lesions detection (+activity assessment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Sep 2018
- Phase
- Interventional
- 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 36 to 83 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Individuals aged 36 months to 83 months;
- Should have complete primary dentition;
- Children must assent to participate and their parents must consent to their participation by signing the consent form.
Who cannot join
- Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
- Children involved in other research that may impact on this study;
- Families who are expected to move out of the coverage area of study during the first year of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth
The present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.
- Conditions
- Dental Caries
- Being tested
- Advanced caries lesions detection (no activity assessment), All caries lesions detection (+activity assessment)
- Keywords
- Dental caries, Primary tooth, Caries Detection
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced caries lesions detection (no activity assessment)Other
Also called WHO criteria, Advanced caries lesions, Extensive Decays
The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.
All caries lesions detection (+activity assessment)Other
Also called Caries activity assessment, initial caries lesions, early detection
The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.
| Study group | Role | What they receive |
|---|---|---|
| Control Caries Detection Strategy | Other | Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment) Receives: Other: Advanced caries lesions detection (no activity assessment) |
| Test Caries Detection Strategy | Other | Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment) Receives: Other: All caries lesions detection (+activity assessment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental number of dental surfaces with operative treatment needs
This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the initial treatment.
Measured: After 12 and 24 months from allocation
Secondary outcomes (3)
Cost-efficacy
The costs of the diagnostic strategy will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization.
Measured: After 12 and 24 months from the allocation
Discomfort
Participants' discomfort, measured by a validated scale (Wong-Baker scale).
Measured: immediately after the allocation and after 12 and 24 months
Impact of oral health on quality of life
Impact of oral health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS).
Measured: 12 and 24 months after the allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Mariana Minatel Braga, University of Sao Paulo
- Investigators
- Mariana M Braga, Principal investigator, University of Sao PauloIsabela Floriano, Principal investigator, University of Sao PauloFausto M Mendes, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473107
- Sponsor's protocol ID
- CARDEC-02
- Status last verified
- Dec 2022
- First submitted
- 9 Jun 2015
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyvad B, Fejerskov O. Assessing the stage of caries lesion activity on the basis of clinical and microbiological examination. Community Dent Oral Epidemiol. 1997 Feb;25(1):69-75. doi: 10.1111/j.1600-0528.1997.tb00901.x.
PubMed 9088694Nyvad B. Diagnosis versus detection of caries. Caries Res. 2004 May-Jun;38(3):192-8. doi: 10.1159/000077754.
PubMed 15153688Baelum V, Heidmann J, Nyvad B. Dental caries paradigms in diagnosis and diagnostic research. Eur J Oral Sci. 2006 Aug;114(4):263-77. doi: 10.1111/j.1600-0722.2006.00383.x.
PubMed 16911097Ismail AI. Clinical diagnosis of precavitated carious lesions. Community Dent Oral Epidemiol. 1997 Feb;25(1):13-23. doi: 10.1111/j.1600-0528.1997.tb00895.x.
PubMed 9088688Pitts NB. Are we ready to move from operative to non-operative/preventive treatment of dental caries in clinical practice? Caries Res. 2004 May-Jun;38(3):294-304. doi: 10.1159/000077769.
PubMed 15153703Ekstrand KR. Improving clinical visual detection--potential for caries clinical trials. J Dent Res. 2004;83 Spec No C:C67-71. doi: 10.1177/154405910408301s13.
PubMed 15286125Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6. doi: 10.12968/denu.2013.40.4.277.
PubMed 23829008Baelum V, Machiulskiene V, Nyvad B, Richards A, Vaeth M. Application of survival analysis to carious lesion transitions in intervention trials. Community Dent Oral Epidemiol. 2003 Aug;31(4):252-60. doi: 10.1034/j.1600-0528.2003.00045.x.
PubMed 12846847Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
PubMed 17518963Piovesan C, Ardenghi TM, Guedes RS, Ekstrand KR, Braga MM, Mendes FM. Activity assessment has little impact on caries parameters reduction in epidemiological surveys with preschool children. Community Dent Oral Epidemiol. 2013 Jun;41(3):204-11. doi: 10.1111/cdoe.12004. Epub 2012 Sep 25.
PubMed 23004568Mendes FM, Braga MM, Oliveira LB, Antunes JL, Ardenghi TM, Bonecker M. Discriminant validity of the International Caries Detection and Assessment System (ICDAS) and comparability with World Health Organization criteria in a cross-sectional study. Community Dent Oral Epidemiol. 2010 Oct;38(5):398-407. doi: 10.1111/j.1600-0528.2010.00557.x.
PubMed 20636415Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.
PubMed 20091655Harris R, Gamboa A, Dailey Y, Ashcroft A. One-to-one dietary interventions undertaken in a dental setting to change dietary behaviour. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006540. doi: 10.1002/14651858.CD006540.pub2.
PubMed 22419315Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.
PubMed 22736448Ricketts DN, Kidd EA, Innes N, Clarkson J. Complete or ultraconservative removal of decayed tissue in unfilled teeth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD003808. doi: 10.1002/14651858.CD003808.pub2.
PubMed 16856019
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARies DEtection in Children - Cost-efficacy, Applicability and Impact on Quality of Life of Detecting Active Initial Caries Lesions in Primary Teeth
- ClinicalTrials.gov ID
- NCT02473107
- Acronym / sponsor ID
- CARDEC-02
- Conditions
- Dental Caries
- Keywords
- Dental caries, Primary tooth, Caries Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 Jun 2015 (estimated)
- 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 present study aims to evaluate the impact of detecting active initial caries lesions in primary teeth regarding effectiveness, cost-effectiveness, applicability (acceptability and satisfaction) and quality of life. For this, 248 children 3-6 years with complete primary dentition will be examined and treated in a mobile dental unit, which will temporarily be parked in public schools of Sao Paulo. The caries detection will be conducted using the International Caries Detection and Assessment System (ICDAS) and, depending on allocation, an adjunct criterion for caries activity assessment. Children will be randomized in two groups according to the caries threshold to be detected: Group A (only advanced lesions will be detected and treated, independently of their activity status) and Group B (all caries lesions, including initial ones, will be detected and all active lesions will be treated). After this, the treatment plan for each child will be made according to strategies mentioned above. Data concerning the cost-effectiveness of the procedures, acceptability / satisfaction of children and quality of life will be collected after diagnosis, after the end of treatment and 12 and 24 months from the initial examination. For comparison between groups, multilevel regression analyses will be performed. The primary outcome will be sites which need of operative treatment during the follow-up periods and the secondary outcomes will be the cost-effectiveness of each strategy, the acceptability / satisfaction of the child and the impact on quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Caries Detection Strategy | Other | Other: Advanced caries lesions detection (no activity assessment)Detection and treatment based on more advanced lesions, despite activity status - Advanced caries lesions detection (no activity assessment) |
| Test Caries Detection Strategy | Other | Other: All caries lesions detection (+activity assessment)Detection and treatment based on all detected caries lesions, considering their activity status as a differential in clinical decision-making - All caries lesions detection (+activity assessment) |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Individuals aged 36 months to 83 months;
- Should have complete primary dentition;
- Children must assent to participate and their parents must consent to their participation by signing the consent form.
Key exclusion criteria (3 listed)
- Medical and/or behavioral conditions that requires special considerations regarding management/treatment of the child;
- Children involved in other research that may impact on this study;
- Families who are expected to move out of the coverage area of study during the first year of enrollment.
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 |
|---|---|---|
| Advanced caries lesions detection (no activity assessment)Also: WHO criteria, Advanced caries lesions, Extensive DecaysThe diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols. | Other | Control Caries Detection Strategy |
| All caries lesions detection (+activity assessment)Also: Caries activity assessment, initial caries lesions, early detectionThe diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated. | Other | Test Caries Detection Strategy |
Primary outcome
Incremental number of dental surfaces with operative treatment needs
Time frame: After 12 and 24 months from allocation
This outcome will be assessed by the new caries lesions and / or progression of lesions previously diagnosed / treated and number of treated surfaces which will need restoration replacement, endodontic treatment or extraction after the initial treatment.
3 secondary outcomes
Cost-efficacy
Time frame: After 12 and 24 months from the allocation
Discomfort
Time frame: immediately after the allocation and after 12 and 24 months
Impact of oral health on quality of life
Time frame: 12 and 24 months after the allocation
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 28 Dec 2022.
- Background: PubMed 9088694Nyvad B, Fejerskov O. Assessing the stage of caries lesion activity on the basis of clinical and microbiological examination. Community Dent Oral Epidemiol. 1997 Feb;25(1):69-75. doi: 10.1111/j.1600-0528.1997.tb00901.x.
- Background: PubMed 15153688Nyvad B. Diagnosis versus detection of caries. Caries Res. 2004 May-Jun;38(3):192-8. doi: 10.1159/000077754.
- Background: PubMed 16911097Baelum V, Heidmann J, Nyvad B. Dental caries paradigms in diagnosis and diagnostic research. Eur J Oral Sci. 2006 Aug;114(4):263-77. doi: 10.1111/j.1600-0722.2006.00383.x.
- Background: PubMed 9088688Ismail AI. Clinical diagnosis of precavitated carious lesions. Community Dent Oral Epidemiol. 1997 Feb;25(1):13-23. doi: 10.1111/j.1600-0528.1997.tb00895.x.
- Background: PubMed 15153703Pitts NB. Are we ready to move from operative to non-operative/preventive treatment of dental caries in clinical practice? Caries Res. 2004 May-Jun;38(3):294-304. doi: 10.1159/000077769.
- Background: PubMed 15286125Ekstrand KR. Improving clinical visual detection--potential for caries clinical trials. J Dent Res. 2004;83 Spec No C:C67-71. doi: 10.1177/154405910408301s13.
- Background: PubMed 23829008Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6. doi: 10.12968/denu.2013.40.4.277.
- Background: PubMed 12846847Baelum V, Machiulskiene V, Nyvad B, Richards A, Vaeth M. Application of survival analysis to carious lesion transitions in intervention trials. Community Dent Oral Epidemiol. 2003 Aug;31(4):252-60. doi: 10.1034/j.1600-0528.2003.00045.x.
- Background: PubMed 17518963Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.
- Background: PubMed 23004568Piovesan C, Ardenghi TM, Guedes RS, Ekstrand KR, Braga MM, Mendes FM. Activity assessment has little impact on caries parameters reduction in epidemiological surveys with preschool children. Community Dent Oral Epidemiol. 2013 Jun;41(3):204-11. doi: 10.1111/cdoe.12004. Epub 2012 Sep 25.
- Background: PubMed 20636415Mendes FM, Braga MM, Oliveira LB, Antunes JL, Ardenghi TM, Bonecker M. Discriminant validity of the International Caries Detection and Assessment System (ICDAS) and comparability with World Health Organization criteria in a cross-sectional study. Community Dent Oral Epidemiol. 2010 Oct;38(5):398-407. doi: 10.1111/j.1600-0528.2010.00557.x.
- Background: PubMed 20091655Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.
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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.
Mariana M Braga principal investigator
University of Sao Paulo
Isabela Floriano principal investigator
University of Sao Paulo
Fausto M Mendes principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced caries lesions detection (no activity assessment) and All caries lesions detection (+activity assessment) in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 3 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 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Incremental number of dental surfaces with operative treatment needs (time frame: After 12 and 24 months from allocation). 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 NCT02473107, which also lists 21 linked publications.
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 28 Dec 2022.