Degeneration; Bone
Conditions
Keywords
GBR, GTR, Dental Implant surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICEbarrier membrane
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
DEVICEMembraGel
Device application at surgery
OTHERBio-Gide® membrane
Device application at surgery
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have voluntarily signed the informed consent form before any study related action * Males and females must be at least 18 years of age and not more than 80 year old. * Have at least one missing tooth in the posterior mandible or maxilla in quadrant 1, 2, 3, 4 (FDI positions 4-7), requiring one or more dental implants. * Partially edentulous patients and patients in need of a fixed dental prosthesis * The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation. * Bone defect(s) must be present with a vertical dimension greater than or equal to 3 mm at the foreseen GBR site measured after dental implant placement. * Full mouth bleeding on Probing (FMBoP) and full mouth plaque score (FMPI) are both lower or equal than 25% * Patients must be committed to the study.
Exclusion criteria
* Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) * Major systemic diseases * Medical conditions requiring prolonged use of steroids * Use of Bisphosphonate intravenously * Current pregnancy or breastfeeding women * Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene * Alcoholism or chronically drug abuse * Immunocompromised patients * Patients who smoke more than 10 cigarettes per day or cigar equivalents, or who chew tobacco * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. Local
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | Assessed at 6 months reported | Change between baseline (regenerative therapy) and the 6 months timepoint is reported. |
Countries
Belgium, Germany, Hungary, Italy, Spain, Sweden, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 45 |
| 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 | 40 |
| Total | 85 |
Baseline characteristics
| Characteristic | MembraGel | Total | Bio-Gide® Membrane |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 14 | 49.8 years STANDARD_DEVIATION 14.3 | 49.1 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 84 Participants | 44 Participants |
| Region of Enrollment Belgium | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment Germany | 16 Participants | 31 Participants | 15 Participants |
| Region of Enrollment Italy | 5 Participants | 13 Participants | 8 Participants |
| Region of Enrollment Spain | 8 Participants | 19 Participants | 11 Participants |
| Region of Enrollment Sweden | 4 Participants | 7 Participants | 3 Participants |
| Region of Enrollment Switzerland | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Female | 33 Participants | 58 Participants | 25 Participants |
| Sex: Female, Male Male | 7 Participants | 27 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 57 | 18 / 60 |
| serious Total, serious adverse events | 0 / 57 | 1 / 60 |
Outcome results
Primary
The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.
Change between baseline (regenerative therapy) and the 6 months timepoint is reported.
Time frame: Assessed at 6 months reported
Population: PP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bio-Gide® Membrane | The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | 3.2 mm | Standard Deviation 2.1 |
| MembraGel | The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. | 2.5 mm | Standard Deviation 1.5 |