Trial Outcomes & Findings for Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia (NCT NCT00639860)

NCT ID: NCT00639860

Last Updated: 2016-03-31

Results Overview

Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

From Baseline to 12 weeks

Results posted on

2016-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Placing OSSIX-Plus in Extraction Site Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Age, Customized	47.7 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Socket width (buccopalatal)	8.3 mm n=5 Participants
Socket width (meiodistal)	5.1 mm n=5 Participants
Stent to buccal plate	5.6 mm n=5 Participants
Stent to mesial osseous crest	4.0 mm n=5 Participants
Stent to distal osseous crest	4.1 mm n=5 Participants
Stent to midosseous crest	4.7 mm n=5 Participants
Stent to apex of socket	16.5 mm n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to 12 weeks

Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Outcome measures

Outcome measures
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Change in Bone Gain or Loss in Millimeters (Buccopalatal)	7.7 mm Interval 0.0 to 10.0

PRIMARY outcome

Timeframe: From Baseline to 12 weeks

Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Outcome measures

Outcome measures
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Change in Bone Gain or Loss in Millimeters (Mesiodistal)	4.6 mm Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: From Baseline to 12 weeks

Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.

Outcome measures

Outcome measures
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Change in Bone Gain or Loss in Millimeters (Stent to Apex)	10.9 mm Interval 3.0 to 20.0

PRIMARY outcome

Timeframe: From Baseline to 12 weeks

Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).

Outcome measures

Outcome measures
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
Radiographic Bone Changes	86.5 percentage of bone fill Interval 0.0 to 100.0

PRIMARY outcome

Timeframe: From Baseline to 12 weeks

Percentage of new bone formation of the alveolar bone core biopsies.

Outcome measures

Outcome measures
Measure	Placing OSSIX-Plus in Extraction Site n=10 Participants Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia. OSSIX-Plus: resorbable collagen membrane
New Bone Formation	46.09 percentage of vital bone Interval 0.0 to 100.0

Adverse Events

Placing OSSIX-Plus in Extraction Site

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine

University of Michigan School of Dentistry

Phone: 734-763-2105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place