Comparing biocompatibility of two dental restoration materials
Randomized Clinical Trial in Children to Evaluate the Biocompatibility of Resin-based Dental Materials
This study is testing which of two dental materials, glass-ionomer or resin-based composites, is safer for kids getting fillings in their back teeth by checking their urine and saliva for certain chemicals.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT02874625 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the biocompatibility of two dental materials: glass-ionomer and resin-based composites. Participants with carious lesions in primary molars will receive one of the two materials for dental restoration. Urine and saliva samples will be collected at various time points to measure bisphenol A levels and analyze estrogenic activity. Additionally, buccal cells will be collected for DNA extraction to assess global alterations in DNA methylation and hydroxymethylation levels.
Who should consider this trial
Good fit: Ideal candidates are children with one or more carious lesions in primary molars that require treatment.
Not a fit: Patients with extensive carious lesions affecting the dental pulp or those with chronic diseases requiring medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer dental restoration materials with reduced health risks for patients.
How similar studies have performed: Other studies have explored the biocompatibility of dental materials, but this specific comparison may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * one or more carious lesions in primary molars that require treatment Exclusion Criteria: * carious lesions that already affected the dental pulp, large lesions requiring cusp replacement, presence of oral inflammatory conditions during the previous 2 weeks, carriage of a fixed or removable prosthesis/orthodontic appliance, chronic disease requiring intake of drugs, exposure to diagnostic X-rays in previous 2 months, previous dental restorations
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.