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

• ClinicalTrials.gov Identifier: NCT01012921
• Recruitment Status: Completed
• First Posted: November 13, 2009
• Results First Posted: January 2, 2018
• Last Update Posted: January 2, 2018
• Sponsor: Institut Straumann AG
• Information provided by (Responsible Party): Institut Straumann AG

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Degeneration; Bone	Device: barrier membrane; Device: MembraGel; Other: Bio-Gide® membrane	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: September 2009
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Institut Straumann AG
• ClinicalTrials.gov Identifier: NCT01012921
• Other Study ID Numbers: CR 07/07
• First Posted: November 13, 2009
• Results First Posted: January 2, 2018
• Last Update Posted: January 2, 2018
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Institut Straumann AG:

GBR; GTR; Dental Implant surgery