Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT01012921
First received: November 11, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Degeneration; Bone
Device: barrier membrane
Device: MembraGel
Other: Bio-Gide® membrane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Straumann® MembraGel Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • non-inferiority of Straumann® MembraGel compared to a standard collagen membrane (Bio-Gide®)used for GBR in defects around Straumann implants. The bone fill will be assessed at baseline compared to 6 months after regenerative therapy. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Change of crestal bone level [ Time Frame: 6 months to 42 months ] [ Designated as safety issue: No ]
  • • Soft tissue parameters [ Time Frame: 6 months to 42 months ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: September 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Device: barrier membrane
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
Other: Bio-Gide® membrane
Device application at surgery
Other Name: Bio-Gide® membrane
Experimental: MembraGel
MembraGel The Straumann membrane is a synthetic degradable barrier membrane
Device: barrier membrane
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
Device: MembraGel
Device application at surgery
Other Name: Straumann® MembraGel

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012921

Locations
Belgium
Catholic University Leuven School of Dentistry, Oral Pathology & Maxillo-facial Surgery
Leuven, Belgium, 3000
Germany
Charite
Berlin, Germany, 14179
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40225
Hungary
Semmelweis University
Budapest, Hungary, 1088
Italy
Eastman Hospital
Rome, Italy
Spain
Prof. Mariano Sanz
Madrid, Spain, 28040
Clinica Blanco Ramos
Santiago de Compostela, Spain, 15701
Sweden
Gävle Hospital
Gävle, Sweden, 80187
Switzerland
Medical University Zürich
Zürich, Switzerland, 8032
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Christoph Haemmerle, Prof. Dr. Medical University Zürich, Switzerland
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT01012921     History of Changes
Other Study ID Numbers: CR 07/07
Study First Received: November 11, 2009
Last Updated: August 6, 2014
Health Authority: Switzerland: Ethikkommission
Belgium: Institutional Review Board
Germany: Ethics Commission
Italy: Ethics Committee
Hungary: Institutional Ethics Committee
Sweden: Institutional Review Board
Spain: Ethics Committee

Keywords provided by Institut Straumann AG:
GBR
GTR
Dental Implant surgery

ClinicalTrials.gov processed this record on August 21, 2014