Recurrent CariesNCT02537327
Incidence of Recurrent Caries Next to Tooth Restorations
An observational study of Recurrent Caries, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Caries
- How many people
- 450 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up
Who may be able to join
- Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up
Who cannot join
- Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)
Trial locations and contacts
1 site in 1 country.
Belgium1 site
KU Leuven and UZ Leuven, Department of oral health sciences
Leuven, 3000
About this study
Official title: Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations
The aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.
Read the detailed description
The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.
- Conditions
- Recurrent Caries
- Keywords
- Recurrent caries, Secondary caries, Dental composite, Dental amalgam
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent caries
Number of recurrent caries lesions (new caries lesion next to restoration) within a specified time period divided by the total number of restorations.
Measured: Two years
Secondary outcomes (1)
Caries risk of the patient
Caries risk of each patient will be assessed based on scoring of several parameters such as: number of new caries lesions in the last 3 years (from patients' files), presence of relevant systemic disease (from patients' files), sugar consumption (from patients' files), oral hygiene (from patients' files) and results of the Saliva-check test and Tri plaque ID test.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CariesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsten L. Van Landuyt, DDS, PhD, Study chair, BIOMAT, Department of Oral Health Sciences, University of Leuven & Dentistry University Hospitals Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537327
- Sponsor's protocol ID
- S56046
- Status last verified
- Jun 2016
- First submitted
- 19 Aug 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on the Incidence and Characteristics of Secondary Caries Next to Tooth Restorations
- ClinicalTrials.gov ID
- NCT02537327
- Acronym / sponsor ID
- S56046
- Conditions
- Recurrent Caries
- Keywords
- Recurrent caries, Secondary caries, Dental composite, Dental amalgam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Sep 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 aim of this study is to determine the incidence of recurrent caries around the different types of restorative materials (composites, amalgam, ceramics, crowns, etc.) and to better characterize recurrent caries lesions in terms of location and size of the lesions and type, material and age of the restoration.
Detailed description
The data will be collected from patients who are visiting the dental clinic for a check-up. These data will be retrieved in the patient records. In particular the clinical (mouth) exam and the radiographic images ('RX-bite-wings'), which are routinely taken during these check-up consultations, will be used for the evaluation of recurrent caries. Information regarding medical background, oral hygiene, sugar eating habits and possible parafunctional activities will also be gathered from the patient files. In addition, caries risk of the patients will be assessed using commercial kits for analysis of their saliva (Saliva-Check Buffer, GC, Tokyo, Japan) and dental plaque (Tri Plaque ID Gel, GC, Tokyo, Japan), which are a part of the routine care of the patients at the clinic.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up
Key inclusion criteria (1 listed)
- Patients visiting the university dental clinic (Department of Oral Health Care) for a dental check-up
Key exclusion criteria (1 listed)
- Patients for who not all necessary data could be registered (incomplete mouth exam records, missing RX-bite wings, etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of recurrent caries
Time frame: Two years
Number of recurrent caries lesions (new caries lesion next to restoration) within a specified time period divided by the total number of restorations.
1 secondary outcome
Caries risk of the patient
Time frame: Two years
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 23 Nov 2016.
Related trials for Recurrent Caries
Not yet recruiting
The Effect of Bulk Filling Flowable Composite on Caries Recurrence in Deep Marginal Elevation: A Randomized Clinical Trial
DME, Dental Caries
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.
Kirsten L. Van Landuyt, DDS, PhD study chair
BIOMAT, Department of Oral Health Sciences, University of Leuven & Dentistry University Hospitals Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Caries, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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 23 Nov 2016. 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 Belgium. 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?
Incidence of recurrent caries (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.