Comparing two collagen membranes for dental implant bone augmentation
A Randomized Controlled Clinical Trial to Compare Two Collagen Membranes for Guided Bone Regeneration (GBR) Around Dental Implants Restored with Monolithic Zirconia Single Crowns Using Three Different Veneering Designs
This study tests whether a new type of collagen membrane can help improve bone stability better than a standard one for people getting dental implants to replace a single tooth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Geneva, Switzerland Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT06724783 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two types of collagen membranes used during bone augmentation procedures for dental implants. Participants will receive an implant with simultaneous bone augmentation and will be monitored for bone stability and the occurrence of ceramic restoration chipping over a period of five years. The study will evaluate whether a new compressed collagen membrane provides better bone stability compared to a standard membrane. The trial focuses on patients needing a single tooth replacement in the aesthetic zone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require an implant-supported crown in the aesthetic region and can undergo a one-stage bone augmentation procedure.
Not a fit: Patients with large bone defects requiring a two-stage augmentation procedure or those with allergies to collagen or implant materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes in bone stability and reduced complications for patients receiving dental implants.
How similar studies have performed: Previous studies have shown promising results with guided bone regeneration techniques, but the specific comparison of these two collagen membranes is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the subject * ≥18 years of age * No active periodontal disease * Full-mouth plaque score and full-mouth bleeding score \<25%. * Patients in need of an implant-supported crown at a single-tooth gap in the aesthetic region: 11-15, 21-25, 31-35, 41-45 (FDI) * Patients in need of GBR during implant placement (1-stage procedure) * Presence of mesial and distal natural teeth or implant * Implant placement at least 6 weeks after tooth extraction * No need for soft tissue grafting Exclusion Criteria: * Any conditions or circumstances which would interfere with the requirements for oral surgery * Patients with large bone defects, in need of a primary bone augmentation (two-stage procedure) * Allergy to any implant metallic component * Allergy to collagen * Previous oral-maxillo-facial radiotherapy * Any disorders in the planned implant area such as previous tumors, chronic bone * disease (such as rheumatoid disease) * Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.) * Alcohol or drug abuse * No need for soft tissue grafting * Patients with inadequate oral hygiene or persistent oral infection * Clinically significant concomitant diseases (e.g. renal failure, hepatic disfunction, cardiovascular diseases) * Heavy smokers (\>10 cigarettes/day) * Uncontrolled diabetes * Severe bruxism or other destructive habits * Pregnant or lactating women
Where this trial is running
Geneva, Canton of Geneva
- University of Geneva — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Malin Strasding, Dr dent med — University Clinic of Dental Medicine, University of Geneva
- Study coordinator: Malin Strasding, Dr dent med
- Email: malin.strasding@unige.ch
- Phone: +41 (0)22 379 40 50
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.