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: June 21, 2013
Last verified: June 2013
  Purpose

The aim of the study is to test in a randomised 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.


Condition Intervention
Bone Dehiscence Defects
Device: Implant surgery

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
This is a biodegradable bilayer membrane for bone and tissue regeneration. It has a natural collagen structure and is of porcine origin.
Device: Implant surgery
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).
Experimental: MembraGel
The Straumann membrane is a synthetic degradable barrier membrane.
Device: Implant surgery
The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).

  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
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: June 21, 2013
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 April 20, 2014