Materials TestingNCT02874599
Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
A study testing Dental restoration in people with Materials Testing, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX. Also buccal cells will be taken. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Materials Testing
- What is being tested?
- Dental restoration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2018to Nov 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian, adults,
Who cannot join
- acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
BIOMAT, Department of Oral Health Sciences
Leuven, 3000
Kirsten L. Van Landuyt, Prof. Dr., +1632373494, siemon.denys@kuleuven.be
Siemon De Nys
About this study
Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.
Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.
- Conditions
- Materials Testing
- Being tested
- Dental restoration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental restorationProcedure or surgery
Damaged teeth will be restored
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients who require multiple dental restorations. Teeth will be restored with commercial restorative composites Receives: Procedure: Dental restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary bisphenol A levels
Measured: 1 year
Salivary bisphenol A levels
Measured: 1 year
%DNA methylation
Measured: 6 months
%DNA hydroxymethylation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start2 May 2018
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Materials TestingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874599
- Sponsor's protocol ID
- S57171
- Status last verified
- Jul 2024
- First submitted
- 17 Aug 2016
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
- ClinicalTrials.gov ID
- NCT02874599
- Acronym / sponsor ID
- S57171
- Conditions
- Materials Testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 2 May 2018 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Aug 2016 (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.
Adult patients who require multiple dental restorations will be included in this study. Urine and saliva samples will be taken for determination of bisphenol A levels at several time points, and for analysis of the estrogenic activity using ERE-CALUX.
Also buccal cells will be taken. Next, DNA extraction will be done with a commercial kit. We will determine global alterations in DNA methylation and DNA hydroxymethylation levels using UPLC-MS/MS.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Procedure: Dental restorationPatients who require multiple dental restorations. Teeth will be restored with commercial restorative composites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caucasian, adults,
Key exclusion criteria (1 listed)
- acute or chronic medical condition, presence of oral inflammatory conditions during the previous 2 weeks, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in the previous 2 months, smoking and consumption of alcohol
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 restorationDamaged teeth will be restored | Procedure or surgery | Patients |
Primary outcome
Urinary bisphenol A levels
Time frame: 1 year
Salivary bisphenol A levels
Time frame: 1 year
%DNA methylation
Time frame: 6 months
%DNA hydroxymethylation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
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 restoration in people with Materials Testing, 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary bisphenol A levels (time frame: 1 year). The study lists 4 primary outcomes in all. 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 3 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.