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

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ClinicalTrials.gov Identifier: NCT00639860
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : March 31, 2016
Last Update Posted : March 31, 2016
Sponsor:
Collaborators:
Johnson & Johnson
OraPharma
Information provided by (Responsible Party):
William Giannobile, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Alveolar Bone Loss
Loss of Teeth Due to Extraction
Edentulous Alveolar Ridge
Intervention Device: OSSIX-Plus
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
47.7
(25 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
6
  60.0%
Male
4
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Socket width (buccopalatal)  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
8.3
(7.0 to 10.0)
Socket width (meiodistal)  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
5.1
(4.0 to 8.0)
Stent to buccal plate  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
5.6
(4.0 to 8.0)
Stent to mesial osseous crest  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
4.0
(2.0 to 6.0)
Stent to distal osseous crest  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
4.1
(2.0 to 6.0)
Stent to midosseous crest  
Mean (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
4.7
(3.0 to 7.0)
Stent to apex of socket  
Median (Full Range)
Unit of measure:  Mm
Number Analyzed 10 participants
16.5
(11.0 to 20.0)
1.Primary Outcome
Title Change in Bone Gain or Loss in Millimeters (Buccopalatal)
Hide Description Socket width (buccopalatal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description:

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: mm
7.7
(0.0 to 10.0)
2.Primary Outcome
Title Change in Bone Gain or Loss in Millimeters (Mesiodistal)
Hide Description Socket width (mesiodistal) measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description:

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: mm
4.6
(0.0 to 8.0)
3.Primary Outcome
Title Change in Bone Gain or Loss in Millimeters (Stent to Apex)
Hide Description Stent to apex of socket measured by a calibrated examiner using a University of North Carolina (UNC) probe.
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description:

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: mm
10.9
(3.0 to 20.0)
4.Primary Outcome
Title Radiographic Bone Changes
Hide Description Radiographic measures were accomplished utilizing a real-time subtraction program, Computer Assisted Radiographic Evaluation (C.A.R.E.).
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description:

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: percentage of bone fill
86.5
(0 to 100)
5.Primary Outcome
Title New Bone Formation
Hide Description Percentage of new bone formation of the alveolar bone core biopsies.
Time Frame From Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description:

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: percentage of vital bone
46.09
(0 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placing OSSIX-Plus in Extraction Site
Hide Arm/Group Description

Placement of OSSIX-Plus, a resorbable collagen membrane, and the promotion of bone healing following exodontia.

OSSIX-Plus: resorbable collagen membrane

All-Cause Mortality
Placing OSSIX-Plus in Extraction Site
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placing OSSIX-Plus in Extraction Site
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placing OSSIX-Plus in Extraction Site
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. William Giannobile, Chair Department of Periodontics and Oral Medicine
Organization: University of Michigan School of Dentistry
Phone: 734-763-2105
Responsible Party: William Giannobile, University of Michigan
ClinicalTrials.gov Identifier: NCT00639860     History of Changes
Other Study ID Numbers: HUM00016574
First Submitted: March 14, 2008
First Posted: March 20, 2008
Results First Submitted: December 11, 2015
Results First Posted: March 31, 2016
Last Update Posted: March 31, 2016