Degeneration; BoneNCT01012921
Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
A study testing barrier membrane, MembraGel and Bio-Gide® membrane in people with Degeneration; Bone, run by Institut Straumann AG at 9 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degeneration; Bone
- What is being tested?
- barrier membrane, MembraGel and Bio-Gide® membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 9 sitesin 7 countries
- Study dates
- Sep 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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 exclusion criteria
- Local inflammation, including untreated periodontitis
- Regenerative treatment necessary adjacent to the planned study site of interest
- Mucosal diseases or oral lesions
- History of local irradiation therapy
- Severe bruxing or clenching habits
- Persistent intraoral infection
- Patients with inadequate oral hygiene or unmotivated for adequate home care
- Previous GBR or GTR treatment at the implant site
- Lack of primary stability of the dental implant at site of interest. In this instance the patient must be withdrawn and the patient treated accordingly (exclusion criteria at surgery)
Trial locations and contacts
9 sites in 7 countries.
9 sites in 7 countries
Germany2 sites
Charite
Berlin, 14179
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Spain2 sites
Prof. Mariano Sanz
Madrid, 28040
Clinica Blanco Ramos
Santiago de Compostela, 15701
Belgium1 site
Catholic University Leuven School of Dentistry, Oral Pathology & Maxillo-facial Surgery
Leuven, 3000
About this study
Official title: Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
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.
Read the 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.
- Conditions
- Degeneration; Bone
- Being tested
- barrier membrane, MembraGel, Bio-Gide® membrane
- Keywords
- GBR, GTR, Dental Implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barrier membraneDevice
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
MembraGelDevice
Also called Straumann® MembraGel
Device application at surgery
Bio-Gide® membraneOther
Device application at surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: barrier membrane; Other: Bio-Gide® membrane |
| MembraGel | Experimental | MembraGel The Straumann membrane is a synthetic degradable barrier membrane Receives: Device: barrier membrane; Device: MembraGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.
Change between baseline (regenerative therapy) and the 6 months timepoint is reported.
Measured: Assessed at 6 months reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Degeneration; BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Straumann AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Haemmerle, Prof. Dr., Principal investigator, Medical University Zürich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012921
- Sponsor's protocol ID
- CR 07/07
- Status last verified
- May 2017
- First submitted
- 11 Nov 2009
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants
- ClinicalTrials.gov ID
- NCT01012921
- Acronym / sponsor ID
- CR 07/07
- Conditions
- Degeneration; Bone
- Keywords
- GBR, GTR, Dental Implant surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Institut Straumann AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Gide® membrane | Active comparator | Device: barrier membrane, Other: Bio-Gide® membraneBio-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 | Device: barrier membrane, Device: MembraGelMembraGel The Straumann membrane is a synthetic degradable barrier membrane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| barrier membraneThe in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). | Device | Bio-Gide® membrane, MembraGel |
| MembraGelAlso: Straumann® MembraGelDevice application at surgery | Device | MembraGel |
| Bio-Gide® membraneDevice application at surgery | Other | Bio-Gide® membrane |
Primary outcome
The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.
Time frame: Assessed at 6 months reported
Change between baseline (regenerative therapy) and the 6 months timepoint is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Haemmerle, Prof. Dr. principal investigator
Medical University Zürich, Switzerland
9 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing barrier membrane, MembraGel and Bio-Gide® membrane in people with Degeneration; Bone, run by Institut Straumann AG at 9 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Spain, Belgium, Hungary, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Bone Fill Was Assessed at 6 Months After Regenerative Therapy. (time frame: Assessed at 6 months reported). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.