Comparison of Two Collagen Membranes for Bone Augmentation Around Dental Implants Restored with Monolithic Zirconia Single Crowns
Recruiting now · Phase 4
Conditions studied: Tooth Extraction, Tooth Replacement
In brief
The goal of this randomized controlled clinical trial is to compare the use of two covering collagen membranes in a bone augmentation procedure around single implants and to assess three different veneering approaches on crowns in patients lacking a single tooth in the esthetic zone. The main aims include: 1. Bone stability, i.e. the difference in the bone defect depth 4 months after bone augmentation 2. The occurrence of ceramic restoration chipping at the inserted single crowns after 5 years. Participants will receive an implant with simultaneous bone augmentation using the bone particles and a covering collagen membrane. After the healing period, they will receive a crown restoration on the implant. In the surgical part, researchers will compare the commonly used collagen membrane with the compressed (stronger) version of the same collagen membrane in an otherwise identical procedure to evaluate if the compressed membrane offers the same or better bone stability. In the restorative part, researchers will compare three types of crown finishes: non-veneered, conventionally veneered and window-veneered (test group) Participants will be asked to come to follow-up appointments over a period of 7 years. Depending on the follow-up time in the study, different dental measurements will be taken to assess the stability of the implants and restorations.
Key facts
- Study ID
- NCT06724783
- Run by
- Dr. med. dent. Malin Strasding
- People needed
- 68
- Starts
- 2023-06-30
- Expected to finish
- 2030-09-30
- Last updated by the study team
- 2024-12-09
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University of Geneva — Geneva, Canton of Geneva, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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