About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed Consent signed by the subject
≥18 years of age
No active periodontal disease
Full-mouth plaque score and full-mouth bleeding score <25%.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Collagen membrane
DeviceImplant placement with simultaneous GBR covered with a collagen membrane
Treatment groups
Trial outcomes
Primary outcomes
Surgical part: bone stability
The difference in the bone defect depth after bone augmentation (baseline) and after 4 months between the groups.
Restorative part: chipping rates
The occurrence of ceramic chipping at the inserted single crowns
Secondary outcomes
Bone level changes
Bone width and mesial and distal bone levels
Soft tissue volume changes
Intraoral digital scans will be analyzed with a software to assess changes in tissue volume over time.
Restoration technical parameters
Prosthetic/functional and aesthetic parameters
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. med. dent. Malin Strasding
Lead sponsor
University of Geneva, Switzerland
Sponsor institution