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

• • 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 ]

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.

• 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.
  Intervention: Device: Implant surgery
• Experimental: MembraGel
  The Straumann membrane is a synthetic degradable barrier membrane.
  Intervention: Device: Implant surgery

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)