Actively Recruiting
Comparison of Biofilm Accumulation on the Surface of Zirconia Versus Titanium Implants Randomized Controlled Pilot Clinical Trial
Led by Universidad Complutense de Madrid · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to compare the amount and type of biofilm that forms on zirconia dental implants versus titanium dental implants. This pilot study will involve 30 patients receiving single implants, aiming to evaluate biofilm accumulation along with other factors such as bleeding on probing, plaque index, keratinized gingiva, marginal bone loss, and patient satisfaction over a 12-month period. The study follows strict ethical guidelines and uses statistical methods to analyze the data for significant differences between implant types. Participants will receive either a two-piece zirconia implant or a two-piece titanium implant to replace a single missing tooth. Implant placement involves surgical procedures including incisions, flap elevation, alveolar ridge preparation, and implant insertion, followed by antibiotic and anti-inflammatory treatments. After healing periods of three months for mandible and four months for maxilla, final screw-retained metal-ceramic crowns are placed. Evaluations occur before crown placement, at six months, and at one year. Patients will undergo sample collections from the implant site to culture bacteria and assess biofilm amounts at specified intervals. Additional assessments include implant survival, probing depth, bleeding on probing, plaque index, keratinized gingiva measurement, and radiographic evaluation of bone loss using specialized software. Data collection is carefully calibrated for reliability, and patients are monitored throughout the study duration of one year after implant placement.
CONDITIONS
Brief Title
Biofilm Accumulation in Zirconia vs. Titanium Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes who are adults (18 years or older)
- Patients classified as ASA I, II, or III
- Patients requiring placement of a single dental implant
- Patients willing to accept surgery and sign informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unable to attend follow-up visits after surgery
- Patients with implants adjacent to the treatment area
- Patients with uncontrolled periodontal disease
- Patients with systemic conditions contraindicating surgery such as infectious diseases, oncological treatment, uncontrolled diabetes, heart conditions, recent stroke or heart attack, immunosuppression, psychiatric disorders, and several other listed systemic diseases
- Patients on certain medications including anticoagulants, antiaggregants, bisphosphonates, monoclonal antibodies, serotonin reuptake inhibitors, immunosuppressants, corticosteroids, and antipsychotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months until final crown placement
Participants undergo placement of a zirconia or titanium dental implant to replace a single missing tooth, including surgery and post-operative care with prescribed medications and instructions.
1 surgical visit and 1 baseline visit before crown placement
Duration - 12 months post crown placement
Participants attend follow-up visits to assess biofilm accumulation, implant survival, probing depth, bleeding on probing, plaque index, keratinized gingiva, and marginal bone loss using radiographs at 6 and 12 months after crown placement.
2 visits (at 6 months and 12 months)
Trial Site Locations
Total: 1 location
1
Complutense University of Madrid
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Jorge JC Cortés-Bretón, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here