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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:
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.
Guided bone regeneration (GBR) is a standard procedure to obtain the necessary bone volume for implant placement. The most frequently performed technique relies on the application of deproteinized bone particles to augment bone volume in combination with a resorbable collagen membrane to hold the particles in place and prevent gingival connective tissue invasion. To improve the elasticity and tenacity of Bio-Gide, a new collagen membrane (compressed) has been developed and placed on the market. Potentially, improved stability of bone particles due to the more firm and rigid characteristics of the new collagen membrane would aid in better space maintenance and bone regeneration around implants.
Prosthetic restorations must be placed on implants to allow normal denture function. One of the major technical complications occurring in metal-ceramic and all-ceramic single and multiple implant-borne fixed dental prostheses (FDPs) is ceramic chipping. In highly aesthetic regions facial veneering is often necessary to overcome the aesthetic limitations of monolithic ceramic ingots. The development of a novel yet standardized approach when designing a "micro-veneered" restoration, namely window veneering, in the dental laboratory may be helpful for the reduction of chipping rates.
The primary objective of the surgery part is to determine whether the application of the new collagen membrane in a one-stage GBR+implant placement procedure results in a similar change of bone level height after 4 months compared to the application of the standard collagen membrane.
The primary objective of the restorative part is to examine the technical outcomes of the ceramic (chipping/ fracture) of three veneering designs of monolithic zirconia crowns (buccal window veneer leaving the incisal edge, standardized buccal micro-veneering or no-veneering, during 5 years of clinical function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard resorbable collagen membrane | Active Comparator | GBR with implant placement |
|
| Compressed, stronger resorbable collagen membrane | Experimental | GBR with implant placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen membrane | Device | Implant placement with simultaneous GBR covered with a collagen membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical part: bone stability | The difference in the bone defect depth after bone augmentation (baseline) and after 4 months between the groups. | 4 months |
| Restorative part: chipping rates | The occurrence of ceramic chipping at the inserted single crowns | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Bone level changes | Bone width and mesial and distal bone levels | 1,3,5 years |
| Soft tissue volume changes | Intraoral digital scans will be analyzed with a software to assess changes in tissue volume over time. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malin Strasding, Dr dent med | Contact | +41 (0)22 379 40 50 | malin.strasding@unige.ch |
| Name | Affiliation | Role |
|---|---|---|
| Malin Strasding, Dr dent med | University Clinic of Dental Medicine, University of Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva | Recruiting | Geneva | Canton of Geneva | Switzerland |
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A two parallel arm (test and control) non-inferiority, prospective, randomized controlled, monocentric, open-label clinical trial (surgical part) A three parallel arm (test, two controls) prospective, randomized controlled, monocentric, open-label clinical trial
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| 1,3,5 years |
| Restoration technical parameters | Prosthetic/functional and aesthetic parameters | 1,3,5 years |