Secondary CariesCaCIANCT03108586
Caries Cognition and Identification in Adults
A study testing Dental treatment in people with Secondary Caries, run by Federal University of Pelotas at 2 sites in Brazil.
Trial summary
This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondary Caries
- 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
- 185 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2016to 1 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients seeking dental treatment at the School of Dentistry;
- Age between 18 and 60 years;
- Patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth.
Who cannot join
- Patients who refuse to participate in the research;
- Patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service;
- Patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the Faculty of Dentistry;
- Patients who reside in other locations and who can not return for periodic follow-up of the interventions.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
School of Dentistry - Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: Caries Associated With Restorations or Sialants Cognition and Identification in Adults
This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.
Read the detailed description
The study will consist of a randomised controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the FDI criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). And the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - conservative group). Patient evaluations will be performed yearly after 12 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.
- Conditions
- Secondary Caries
- Being tested
- Dental treatment
- Keywords
- restorations, diagnosis, secondary caries, treatment decision
- Medical subject headings
- 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 adults related or not to the dental caries
Dental treatmentProcedure or surgery
Dental treatment of all dental needs present in adults related or not to the dental caries
| Study group | Role | What they receive |
|---|---|---|
| FDI - tradional group | Active comparator | Diagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI). Receives: Procedure: Dental treatment |
| CARS - conservative group | Experimental | Diagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria. Receives: Procedure: Dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of surfaces restored requiring new intervention
The primary endpoint will be the number of surfaces restored requiring intervention, which is composed of the sum of components with different levels of severity: number of surfaces with new caries lesions, number of surfaces restored in need of repair, replacement, teeth with episodes of pain, teeth requiring endodontic treatment or extraction.
Measured: 12 months, 24 months
Secondary outcomes (2)
Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14)
Measured: 12 months, 24 months
Cost-effectiveness measured by a scale
Effectiveness will be measured through the number of restored surfaces without intervention. The cost-effectiveness ratio will be expressed by the cost ratio of the FDI and CARS criteria and effectiveness (number of surfaces without the need for new interventions)
Measured: 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Sep 2016
- Primary completion1 Dec 2022
- Study completion1 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Secondary CariesStudies 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
- 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
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Maximiliano Cenci, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108586
- Sponsor's protocol ID
- UFPEL- PPGO 0020
- Acronym
- CaCIA
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2017
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Signori C, Moro BLP, Uehara JLS, Romero VHD, de Oliveira EF, Braga MM, Mendes FM, Cenci MS; CaCIA Collaborative Group. Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial. BMC Oral Health. 2020 Nov 10;20(1):317. doi: 10.1186/s12903-020-01307-z.
PubMed 33172449Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774Brouwer F, Askar H, Paris S, Schwendicke F. Detecting Secondary Caries Lesions: A Systematic Review and Meta-analysis. J Dent Res. 2016 Feb;95(2):143-51. doi: 10.1177/0022034515611041. Epub 2015 Oct 13.
PubMed 26464398
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Associated With Restorations or Sialants Cognition and Identification in Adults
- ClinicalTrials.gov ID
- NCT03108586
- Acronym / sponsor ID
- CaCIA / UFPEL- PPGO 0020
- Conditions
- Secondary Caries
- Keywords
- restorations, diagnosis, secondary caries, treatment decision
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2032 (estimated)
- First posted
- 11 Apr 2017 (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.
This study will evaluate the effect of the International Dental Federation (FDI) criteria, compared to CARS (Caries Associated with Restorations or Sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.
Detailed description
The study will consist of a randomised controlled trial of two parallel groups. One group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the FDI criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). And the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "Caries Associated with Restorations or Sealants" (CARS) - ICCMS (International Caries Classification and Management System) - conservative group). Patient evaluations will be performed yearly after 12 months. The primary outcome will be the number of surfaces restored with the need for new interventions. Secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.
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 |
|---|---|---|
| FDI - tradional group | Active comparator | Procedure: Dental treatmentDiagnosis and dental treatment decision based on the criteria of the International Dental Federation (FDI). |
| CARS - conservative group | Experimental | Procedure: Dental treatmentDiagnosis and dental treatment decision according to CARS (Caries Associated with Restorations or Sealants) detection criteria. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients seeking dental treatment at the School of Dentistry;
- Age between 18 and 60 years;
- Patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth.
Key exclusion criteria (4 listed)
- Patients who refuse to participate in the research;
- Patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service;
- Patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the Faculty of Dentistry;
- Patients who reside in other locations and who can not return for periodic follow-up of the interventions.
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 adults related or not to the dental caries | Procedure or surgery | FDI - tradional group |
| Dental treatmentDental treatment of all dental needs present in adults related or not to the dental caries | Procedure or surgery | CARS - conservative group |
Primary outcome
Change from baseline in number of surfaces restored requiring new intervention
Time frame: 12 months, 24 months
The primary endpoint will be the number of surfaces restored requiring intervention, which is composed of the sum of components with different levels of severity: number of surfaces with new caries lesions, number of surfaces restored in need of repair, replacement, teeth with episodes of pain, teeth requiring endodontic treatment or extraction.
2 secondary outcomes
Impact of intervention on quality of life measured by a validated questionnaire - OHIP-14 (Oral Health Impact Profile-14)
Time frame: 12 months, 24 months
Cost-effectiveness measured by a scale
Time frame: 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 33172449Signori C, Moro BLP, Uehara JLS, Romero VHD, de Oliveira EF, Braga MM, Mendes FM, Cenci MS; CaCIA Collaborative Group. Study protocol for a diagnostic randomized clinical trial to evaluate the effect of the use of two clinical criteria in the assessment of caries lesions around restorations in adults: the Caries Cognition and Identification in Adults (CaCIA) trial. BMC Oral Health. 2020 Nov 10;20(1):317. doi: 10.1186/s12903-020-01307-z.
- Results publication: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Results publication: PubMed 26464398Brouwer F, Askar H, Paris S, Schwendicke F. Detecting Secondary Caries Lesions: A Systematic Review and Meta-analysis. J Dent Res. 2016 Feb;95(2):143-51. doi: 10.1177/0022034515611041. Epub 2015 Oct 13.
- 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.
Maximiliano Cenci, PhD principal investigator
Federal University of Pelotas
2 sites 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 Secondary Caries, run by Federal University of Pelotas at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in number of surfaces restored requiring new intervention (time frame: 12 months, 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 NCT03108586, which also lists 3 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 Apr 2023.