Evaluating the safety of dental materials in adults
Cohort Biomonitoring Study to Evaluate the Biocompatibilty of Resin-based Dental Materials
This study is testing if certain dental materials are safe for adults by checking their urine and saliva for chemical levels and looking at changes in their DNA.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT02874599 on ClinicalTrials.gov |
What this trial studies
This study involves adult patients who need multiple dental restorations. Participants will provide urine and saliva samples at various time points to measure bisphenol A levels and assess estrogenic activity. Additionally, buccal cells will be collected for DNA extraction, allowing researchers to analyze changes in DNA methylation and hydroxymethylation levels. The goal is to evaluate the biocompatibility of resin-based dental materials used in restorations.
Who should consider this trial
Good fit: Ideal candidates are Caucasian adults requiring multiple dental restorations.
Not a fit: Patients with acute or chronic medical conditions, oral inflammatory conditions, or those who smoke or consume alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer dental materials that minimize health risks for patients.
How similar studies have performed: While similar studies have been conducted, this specific approach to evaluating resin-based dental materials is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caucasian, adults, Exclusion Criteria: * 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
Where this trial is running
Leuven
- BIOMAT, Department of Oral Health Sciences — Leuven, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.