Trial Outcomes & Findings for Comparison of a PEG Membrane and a Collagen Membrane for the Treatment of Bone Dehiscence Defects at Bone Level Implants (NCT NCT01012921)

NCT ID: NCT01012921

Last Updated: 2018-01-02

Results Overview

Change between baseline (regenerative therapy) and the 6 months timepoint is reported.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 117 participants
• Primary outcome timeframe: Assessed at 6 months reported
• Results posted on: 2018-01-02

Participant Flow

Participant milestones

Measure	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 barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery	MembraGel MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery
Overall Study STARTED	57	60
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	10	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bio-Gide® Membrane n=45 Participants 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 barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery	MembraGel n=40 Participants MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery	Total n=85 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 14.7 • n=5 Participants	50.6 years STANDARD_DEVIATION 14.0 • n=7 Participants	49.8 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	7 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Sweden	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Italy	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Switzerland	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment Germany	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Spain	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at 6 months reported

Population: PP

Change between baseline (regenerative therapy) and the 6 months timepoint is reported.

Outcome measures

Measure	Bio-Gide® Membrane n=45 Participants 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 barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery	MembraGel n=40 Participants MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery
The Bone Fill Was Assessed at 6 Months After Regenerative Therapy.	3.2 mm Standard Deviation 2.1	2.5 mm Standard Deviation 1.5

Adverse Events

Bio-Gide® Membrane

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

MembraGel

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bio-Gide® Membrane n=57 participants at risk 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 barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery	MembraGel n=60 participants at risk MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery
Nervous system disorders Cerebral hemorrhagic infarction	0.00% 0/57	1.7% 1/60 • Number of events 1

Other adverse events

Measure	Bio-Gide® Membrane n=57 participants at risk 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 barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). Bio-Gide® membrane: Device application at surgery	MembraGel n=60 participants at risk MembraGel The Straumann membrane is a synthetic degradable barrier membrane barrier membrane: The in situ forming gel serves as a barrier membrane for Guided Bone Regeneration (GBR). MembraGel: Device application at surgery
Infections and infestations Infection	3.5% 2/57	16.7% 10/60
Infections and infestations Delayed epithelisation	1.8% 1/57	3.3% 2/60
Infections and infestations Swelling	1.8% 1/57	3.3% 2/60
Immune system disorders Allergy	1.8% 1/57	1.7% 1/60
General disorders Dehiscence	1.8% 1/57	1.7% 1/60
General disorders Lack of osseointegration	0.00% 0/57	3.3% 2/60
Infections and infestations Pain	0.00% 0/57	1.7% 1/60

Additional Information

Julia Dorn

Institut Straumann AG

Phone: 0041619651111

Email: julia.dorn@straumann.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place