Investigating biofilm formation on temporary dental implant components
Temporary push-on Rings of Antimicrobial Alloys for Transmucosal Implant Abutment Systems: a Randomized Clinical Study on Early and Mature Biofilm Formation
This study is testing if a new type of dental implant material can reduce harmful bacteria buildup compared to the standard material to help prevent gum diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05122897 on ClinicalTrials.gov |
What this trial studies
This study examines the formation and composition of oral biofilm on temporary push-on cones made from a noble-alloy material compared to a titanium alloy used in dental implants. It evaluates biofilm development at three time points: early (48 hours), mature (2 weeks), and long-term (3 months). The goal is to determine if the new material can reduce bacterial colonization and the risk of peri-implant diseases compared to the current standard. Participants will be monitored for biofilm accumulation and related outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals with one or more bone-level titanium implants who are not experiencing systemic illness or active periodontitis.
Not a fit: Patients with systemic illnesses, heavy smokers, or those with active periodontitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental implant materials that reduce the risk of peri-implantitis and enhance oral health.
How similar studies have performed: Other studies have shown promising results with similar approaches in reducing biofilm accumulation on dental materials, suggesting potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the subject * Presence of one or more bone level titanium implant prior to insertion of the final restoration * No systemic illness * No heavy smoking (smoking \<10 cigarettes/day) * No pregnancy * No active periodontitis (probing pocket depth ≤4 mm) * No pharmacological treatment or antibiotic therapy during or up to three months before the study Exclusion Criteria: * Systemic illness (e.g. Diabetes) * Heavy smoking (smoking \>10 cigarettes/day) * Known or suspected non-compliance, drug or alcohol abuse * Pregnancy * Active periodontitis (probing pocket depth \>4 mm) * Pharmacological treatment or antibiotic therapy during or up to three months before the study
Where this trial is running
Basel
- UZB (University Center for Dental Medicine Basel) — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nicola U. Zitzmann, Prof. Dr. — University Center for Dental Medicine Basel
- Study coordinator: Nicola U. Zitzmann, Prof. Dr.
- Email: n.zitzmann@unibas.ch
- Phone: +41 61 267 26 36
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.