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The aim of the study is to test in a randomized comparative study the performance of Straumann® MembraGel (PEG Membrane) to act as a barrier for guided bone regeneration compared to that of a standard collagen membrane (BioGide®) in the bone regeneration around Straumann® SLActive bone level titanium implants.
Furthermore the clinical evaluation and comparison of complementary parameters describing the bony and soft tissue environments at the surgical sites during the study period to evaluate effectiveness and performance of the membranes.
At the primary endpoint of the study - 6 month post-operative - the vertical bone gain will be measured for changes.
The changes will be evaluated by measuring the distance between the implant shoulder and the first visible bone contact on the implant. The measurement will be taken on the medial and distal aspect on the implant at site of interest. Measurements will take into account distortion based on changes on the radiograph from the true dimension of the implant.
Intra-oral photographs will be taken at each study visit to document the initial appearance of the soft tissue and the subsequent healing of the soft tissue post-implant placement. The photographs will be taken buccal and occlusial at study site of interest.
The physical appearance of soft tissue (form, colour, tissue biotype, surface aspect) will be clinically assessed by visual inspection.
In addition changes in the high of the keratinized gingiva will be assessed in mm. This will be measured mid-crestal in buccal direction to the mucogingival border by a periodontal probe.
Changes in gingival recession will be measured at the implant leading visit and the yearly follow-up visit 18, 30 and 42 month post surgery. The distance between the margin of the gingiva and the edge of the crown will be assessed at accessible buccal, palatal, distal and medial sites.
A measurement of vertical defect height will be performed evaluating the distance of the implant shoulder to the first bone to implant contact at surgery visit and 6-month later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Gide® membrane | Active Comparator | Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin |
|
| MembraGel | Experimental | MembraGel The Straumann membrane is a synthetic degradable barrier membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| barrier membrane | Device | The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | Change between baseline (regenerative therapy) and the 6 months timepoint is reported. | Assessed at 6 months reported |
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Inclusion Criteria:
Exclusion Criteria:
Local exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Haemmerle, Prof. Dr. | Medical University Zürich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University Leuven School of Dentistry, Oral Pathology & Maxillo-facial Surgery | Leuven | 3000 | Belgium | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bio-Gide® Membrane | Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MembraGel | Device | Device application at surgery |
|
|
| Bio-Gide® membrane | Other | Device application at surgery |
|
| Charite |
| Berlin |
| 14179 |
| Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40225 | Germany |
| Semmelweis University | Budapest | 1088 | Hungary |
| Eastman Hospital | Rome | Italy |
| Prof. Mariano Sanz | Madrid | 28040 | Spain |
| Clinica Blanco Ramos | Santiago de Compostela | 15701 | Spain |
| Gävle Hospital | Gävle | 80187 | Sweden |
| Medical University Zürich | Zurich | 8032 | Switzerland |
| MembraGel |
MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery |
| COMPLETED |
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| NOT COMPLETED |
|
Analysis population is PP
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| ID | Title | Description |
|---|---|---|
| BG000 | Bio-Gide® Membrane | Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery |
| BG001 | MembraGel | MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | Change between baseline (regenerative therapy) and the 6 months timepoint is reported. | PP | Posted | Mean | Standard Deviation | mm | Assessed at 6 months reported |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bio-Gide® Membrane | Bio-Gide® membrane This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery | 0 | 57 | 6 | 57 | ||
| EG001 | MembraGel | MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery | 1 | 60 | 18 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral hemorrhagic infarction | Nervous system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations |
| |||
| Delayed epithelisation | Infections and infestations |
| |||
| Swelling | Infections and infestations |
| |||
| Allergy | Immune system disorders |
| |||
| Dehiscence | General disorders |
| |||
| Lack of osseointegration | General disorders |
| |||
| Pain | Infections and infestations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Dorn | Institut Straumann AG | 0041619651111 | julia.dorn@straumann.com |
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Belgium |
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| Italy |
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| Switzerland |
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| Germany |
|
| Spain |
|