Dental CariesCARDEC-1NCT02078453
Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth
A study testing Dental treatment in people with Dental Caries and Teeth Loss, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Radiographs have been used to aid dentists in detecting the presence of cavities in the deciduous teeth of children. This procedure is globally recommended because the conventional clinical examination usually overlooks some cavities. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Teeth Loss, Quality of Life
- What is being tested?
- Dental treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Feb 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
- Children aged 3 to 6 years
- Children with al least one primary molar in the mouth.
Who cannot join
- Children whose parents refuse to participate of the research
- Children presenting behavior problems during the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CARies DEtection in Children - Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth
Radiographs have been used to aid dentists in detecting the presence of cavities in the deciduous teeth of children. This procedure is globally recommended because the conventional clinical examination usually overlooks some cavities. However, the real benefit of performing dental radiographs for this purpose is still unclear. Besides the hazards of ionizing radiation, the radiographs could provoke overtreatment of the children; hence, dentists would tend to restore more teeth than would be really necessary. Nowadays, it is preferable to overlook some cavities than treat the teeth unnecessarily. Therefore, the investigators aimed to perform this study to compare two different strategies for detecting cavities in deciduous teeth of children: one based on clinical examination performed alone and other using radiographs adjunct to the clinical examination. To compare these strategies, the investigators will consider outcomes related to children's health and welfare.
Read the detailed description
Despite most clinical guidelines throughout the world indicate that the clinicians take two bitewings for detecting caries lesions in primary molars of asymptomatic children, the evidence for this recommendation is based in cross-sectional studies performed in laboratorial setting or using convenience samples. The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, considering relevant outcomes for the patients, have not been evaluated yet. Thus, the aim of this study will be to evaluate the impact of performing radiographic examination for detecting caries lesions in primary teeth compared with the visual inspection performed alone, considering different outcomes related to the validity and children's health and welfare. For this, three different studies will be carried out according the following specific aims: (1) to evaluate the validity of radiographic examination adjunct to the visual inspection in detecting proximal caries lesions in primary molars in children with low and high caries experience through a cross-sectional design; (2) to evaluate the impact of radiographic examination adjunct to the visual inspection on the diagnostic and treatment decision of caries lesions in primary teeth in a before and after study; and (3) to evaluate the impact of radiographic examination adjunct to the visual inspection for detecting caries lesions in primary teeth on operative needs in the follow-ups and impact of oral health on the quality of life through a randomized clinical trial. To reach these objectives, 250 children aged 3 to 6 years who looked for dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone (control group) or visual inspection associated to radiographic examination (experimental group). After elaboration of treatment decision plan for two examiners, the children will be treated and followed-up for 2 years, with evaluations after 12 and 24 months after the ingress of the children in the study. The primary outcome will be the number of dental surfaces with dental treatment need in the follow-up, considering the aim (3). Then, children allocated in the control group will be reevaluated using radiographic examination, and the performance of two strategies for detecting proximal caries lesions will be evaluated, using temporary separation with orthodontic rubbers for one week as reference standard method. Moreover, a new treatment plan will be performed and compared with the treatment plan based on visual inspection alone. These two parts of the research will be carried out to reach the aims (1) and (2), respectively. Our working hypothesis is that the radiographic examination would actually exert little influence on outcomes related to the validity and children's health and welfare, and that visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.
- Conditions
- Dental Caries, Teeth Loss, Quality of Life
- Being tested
- Dental treatment
- Keywords
- Dental caries, Diagnosis, Visual inspection, Radiographic examination
- Medical subject headings
- Dental Caries, Anodontia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental treatmentProcedure or surgery
Dental treatment of all dental needs present in the children related or not to the dental caries.
| Study group | Role | What they receive |
|---|---|---|
| Visual inspection | Active comparator | Dental treatment performed according to the caries diagnosis obtained with visual inspection performed alone Receives: Procedure: Dental treatment |
| Radiographic examination | Experimental | Dental treatment performed according to the caries diagnosis obtained with visual inspection and additional radiographic method. Receives: Procedure: Dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dental surfaces with operative treatment needs
The number of dental surfaces with operative treatment needs after the follow-ups will be composed by number of surfaces with new caries lesions; number of restored surfaces with necessity of replacement; tooth with pain episode and/or necessity of endodontic treatment and tooth indicated for extraction.
Measured: 24 months
Secondary outcomes (4)
Number of surfaces with new caries lesions
Dental surfaces presenting caries lesions in the foloow-up examinations that require operative treatment.
Measured: 24 months
Number of restored surfaces with necessity of replacement
Number of restored dental surfaces that requires repair or replacement.
Measured: 24 months
Episodes of dental pain and/or primary teeth with pulpal involvement
Number of primary teeth that presented pain episodes or that require endodontic treatment in the follow-up examinations
Measured: 24 months
Primary teeth indicated for extraction due to caries
Number of primary teeth indicated for extraction due caries involvment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Fausto Medeiros Mendes, University of Sao Paulo
- Investigators
- Fausto M Mendes, PhD, Principal investigator, School of Dentistry, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078453
- Sponsor's protocol ID
- CARDEC-01
- Acronym
- CARDEC-1
- Status last verified
- May 2020
- First submitted
- 25 Feb 2014
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.
PubMed 28931398Pontes LRA, Novaes TF, Lara JS, Moro BLP, Gimenez T, Raggio DP, Braga MM, Mendes FM. Impact of the radiographic method on treatment decisions related to dental caries in primary molars: a before-after study. Clin Oral Investig. 2019 Nov;23(11):4075-4081. doi: 10.1007/s00784-019-02844-w. Epub 2019 Feb 18.
PubMed 30778687Freitas JG, Pontes LRA, Acosta CP, Novaes TF, Lara JS, Gimenez T, Ardenghi TM, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2-Year randomized clinical trial. Community Dent Oral Epidemiol. 2023 Oct;51(5):804-812. doi: 10.1111/cdoe.12765. Epub 2022 Jun 7.
PubMed 35670271Pontes LRA, Lara JS, Novaes TF, Freitas JG, Gimenez T, Moro BLP, Maia HCM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Negligible therapeutic impact, false-positives, overdiagnosis and lead-time are the reasons why radiographs bring more harm than benefits in the caries diagnosis of preschool children. BMC Oral Health. 2021 Mar 31;21(1):168. doi: 10.1186/s12903-021-01528-w.
PubMed 33789655Pontes LRA, Novaes TF, Lara JS, Gimenez T, Moro BLP, Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Mendes FM. Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study. J Am Dent Assoc. 2020 Jun;151(6):407-415.e1. doi: 10.1016/j.adaj.2020.02.008.
PubMed 32450979Mendes FM, Pontes LR, Gimenez T, Lara JS, de Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Novaes TF; CARDEC Collaborative Group. Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:69. doi: 10.1186/s13063-016-1196-5.
PubMed 26857821
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARies DEtection in Children - Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth
- ClinicalTrials.gov ID
- NCT02078453
- Acronym / sponsor ID
- CARDEC-1 / CARDEC-01
- Conditions
- Dental Caries, Teeth Loss, Quality of Life
- Keywords
- Dental caries, Diagnosis, Visual inspection, Radiographic examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Mar 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Mar 2014 (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.
Radiographs have been used to aid dentists in detecting the presence of cavities in the deciduous teeth of children. This procedure is globally recommended because the conventional clinical examination usually overlooks some cavities. However, the real benefit of performing dental radiographs for this purpose is still unclear. Besides the hazards of ionizing radiation, the radiographs could provoke overtreatment of the children; hence, dentists would tend to restore more teeth than would be really necessary. Nowadays, it is preferable to overlook some cavities than treat the teeth unnecessarily. Therefore, the investigators aimed to perform this study to compare two different strategies for detecting cavities in deciduous teeth of children: one based on clinical examination performed alone and other using radiographs adjunct to the clinical examination. To compare these strategies, the investigators will consider outcomes related to children's health and welfare.
Detailed description
Despite most clinical guidelines throughout the world indicate that the clinicians take two bitewings for detecting caries lesions in primary molars of asymptomatic children, the evidence for this recommendation is based in cross-sectional studies performed in laboratorial setting or using convenience samples. The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, considering relevant outcomes for the patients, have not been evaluated yet. Thus, the aim of this study will be to evaluate the impact of performing radiographic examination for detecting caries lesions in primary teeth compared with the visual inspection performed alone, considering different outcomes related to the validity and children's health and welfare. For this, three different studies will be carried out according the following specific aims: (1) to evaluate the validity of radiographic examination adjunct to the visual inspection in detecting proximal caries lesions in primary molars in children with low and high caries experience through a cross-sectional design; (2) to evaluate the impact of radiographic examination adjunct to the visual inspection on the diagnostic and treatment decision of caries lesions in primary teeth in a before and after study; and (3) to evaluate the impact of radiographic examination adjunct to the visual inspection for detecting caries lesions in primary teeth on operative needs in the follow-ups and impact of oral health on the quality of life through a randomized clinical trial. To reach these objectives, 250 children aged 3 to 6 years who looked for dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone (control group) or visual inspection associated to radiographic examination (experimental group). After elaboration of treatment decision plan for two examiners, the children will be treated and followed-up for 2 years, with evaluations after 12 and 24 months after the ingress of the children in the study. The primary outcome will be the number of dental surfaces with dental treatment need in the follow-up, considering the aim (3). Then, children allocated in the control group will be reevaluated using radiographic examination, and the performance of two strategies for detecting proximal caries lesions will be evaluated, using temporary separation with orthodontic rubbers for one week as reference standard method. Moreover, a new treatment plan will be performed and compared with the treatment plan based on visual inspection alone. These two parts of the research will be carried out to reach the aims (1) and (2), respectively. Our working hypothesis is that the radiographic examination would actually exert little influence on outcomes related to the validity and children's health and welfare, and that visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.
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 |
|---|---|---|
| Visual inspection | Active comparator | Procedure: Dental treatmentDental treatment performed according to the caries diagnosis obtained with visual inspection performed alone |
| Radiographic examination | Experimental | Procedure: Dental treatmentDental treatment performed according to the caries diagnosis obtained with visual inspection and additional radiographic method. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
- Children aged 3 to 6 years
- Children with al least one primary molar in the mouth.
Key exclusion criteria (2 listed)
- Children whose parents refuse to participate of the research
- Children presenting behavior problems during the treatment.
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 |
|---|---|---|
| Dental treatmentDental treatment of all dental needs present in the children related or not to the dental caries. | Procedure or surgery | Radiographic examination, Visual inspection |
Primary outcome
Number of dental surfaces with operative treatment needs
Time frame: 24 months
The number of dental surfaces with operative treatment needs after the follow-ups will be composed by number of surfaces with new caries lesions; number of restored surfaces with necessity of replacement; tooth with pain episode and/or necessity of endodontic treatment and tooth indicated for extraction.
4 secondary outcomes
Number of surfaces with new caries lesions
Time frame: 24 months
Number of restored surfaces with necessity of replacement
Time frame: 24 months
Episodes of dental pain and/or primary teeth with pulpal involvement
Time frame: 24 months
Primary teeth indicated for extraction due to caries
Time frame: 24 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 26 May 2020.
- Results publication: PubMed 28931398Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.
- Results publication: PubMed 30778687Pontes LRA, Novaes TF, Lara JS, Moro BLP, Gimenez T, Raggio DP, Braga MM, Mendes FM. Impact of the radiographic method on treatment decisions related to dental caries in primary molars: a before-after study. Clin Oral Investig. 2019 Nov;23(11):4075-4081. doi: 10.1007/s00784-019-02844-w. Epub 2019 Feb 18.
- Derived from this study: PubMed 35670271Freitas JG, Pontes LRA, Acosta CP, Novaes TF, Lara JS, Gimenez T, Ardenghi TM, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2-Year randomized clinical trial. Community Dent Oral Epidemiol. 2023 Oct;51(5):804-812. doi: 10.1111/cdoe.12765. Epub 2022 Jun 7.
- Derived from this study: PubMed 33789655Pontes LRA, Lara JS, Novaes TF, Freitas JG, Gimenez T, Moro BLP, Maia HCM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Negligible therapeutic impact, false-positives, overdiagnosis and lead-time are the reasons why radiographs bring more harm than benefits in the caries diagnosis of preschool children. BMC Oral Health. 2021 Mar 31;21(1):168. doi: 10.1186/s12903-021-01528-w.
- Derived from this study: PubMed 32450979Pontes LRA, Novaes TF, Lara JS, Gimenez T, Moro BLP, Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Mendes FM. Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study. J Am Dent Assoc. 2020 Jun;151(6):407-415.e1. doi: 10.1016/j.adaj.2020.02.008.
- Derived from this study: PubMed 26857821Mendes FM, Pontes LR, Gimenez T, Lara JS, de Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Novaes TF; CARDEC Collaborative Group. Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:69. doi: 10.1186/s13063-016-1196-5.
- Individual participant dataSharing planned: No
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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.
Fausto M Mendes, PhD principal investigator
School of Dentistry, 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 Dental treatment in people with Dental Caries and Teeth Loss, 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 2 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 26 May 2020. 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?
Number of dental surfaces with operative treatment needs (time frame: 24 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 NCT02078453, which also lists 6 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 26 May 2020.