NCT01012921

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Institut Straumann AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	Bio-Gide® membrane	Device application at surgery

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-10-01
• Completion: 2015-12-01
• First posted: 2009-11-13
• Last updated: 2018-01-02
• Results posted: 2018-01-02

Locations

9 sites across 7 countries: Belgium, Germany, Hungary, Italy, Spain, Sweden, Switzerland