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

NCT ID: NCT01012921

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Degeneration; Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

barrier membrane

Intervention Type: DEVICE

The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).

Bio-Gide® membrane

Intervention Type: OTHER

Device application at surgery

MembraGel

MembraGel The Straumann membrane is a synthetic degradable barrier membrane

Group Type: EXPERIMENTAL

barrier membrane

Intervention Type: DEVICE

The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).

MembraGel

Intervention Type: DEVICE

Device application at surgery

Interventions

barrier membrane

The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR).

Intervention Type: DEVICE

MembraGel

Device application at surgery

Intervention Type: DEVICE

Bio-Gide® membrane

Device application at surgery

Intervention Type: OTHER

Other Intervention Names

Straumann® MembraGel

Eligibility 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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Haemmerle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University Zürich, Switzerland

Locations

Catholic University Leuven School of Dentistry, Oral Pathology & Maxillo-facial Surgery

Leuven, , Belgium

Charite

Berlin, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Semmelweis University

Budapest, , Hungary

Eastman Hospital

Rome, , Italy

Prof. Mariano Sanz

Madrid, , Spain

Clinica Blanco Ramos

Santiago de Compostela, , Spain

Gävle Hospital

Gävle, , Sweden

Medical University Zürich

Zurich, , Switzerland

Countries

Belgium; Germany; Hungary; Italy; Spain; Sweden; Switzerland

Other Identifiers

CR 07/07

Identifier Type: -

Identifier Source: org_study_id