Trial Outcomes & Findings for Ridge Preservation Using a Ossix™ Bone vs Bio-Oss® Collagen (NCT NCT04338516)
NCT ID: NCT04338516
Last Updated: 2025-12-15
Results Overview
shows the amount of new bone formed after the procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-12-15
Participant Flow
Participant milestones
| Measure |
Bio-Oss® Collagen,
subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)
Bio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen
|
Ossix™ Bone
subjects treated with Ossix™ Bone (Datum Dental Ltd)
Ossix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BioOss Collagen
n=27 Participants
no adverse events were observed
|
Ossix™ Bone
n=27 Participants
no adverse events were observed
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=27 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=54 Participants
|
|
Age, Continuous
|
55 YEARS
n=27 Participants
|
55 YEARS
n=27 Participants
|
55 YEARS
n=54 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=27 Participants
|
13 Participants
n=27 Participants
|
26 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=27 Participants
|
14 Participants
n=27 Participants
|
28 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
27 participants
n=27 Participants
|
54 participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 16 weeksshows the amount of new bone formed after the procedure
Outcome measures
| Measure |
Ossix™ Bone
n=21 Participants
subjects treated with Ossix™ Bone (Datum Dental Ltd)
Ossix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
|
Bio-Oss® Collagen,
n=23 Participants
subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)
Bio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen
|
|---|---|---|
|
Percent Vital Bone Formation,
|
39.3 percentage of vital bone
Standard Deviation 17.8
|
26.8 percentage of vital bone
Standard Deviation 15.8
|
PRIMARY outcome
Timeframe: 16 weeksshows how much of the graft material remained intact
Outcome measures
| Measure |
Ossix™ Bone
n=21 Participants
subjects treated with Ossix™ Bone (Datum Dental Ltd)
Ossix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
|
Bio-Oss® Collagen,
n=23 Participants
subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)
Bio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen
|
|---|---|---|
|
Percent Residual Graft Material
|
0 percentage of residual graft
Standard Deviation 0
|
17.9 percentage of residual graft
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: 16 weeksamount of tissue that is neither native bone or graft material
Outcome measures
| Measure |
Ossix™ Bone
n=21 Participants
subjects treated with Ossix™ Bone (Datum Dental Ltd)
Ossix™ Bone: a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
|
Bio-Oss® Collagen,
n=23 Participants
subjects treated with Bio-Oss® Collagen, (Geistlich, Inc.)
Bio-Oss® Collagen: 90% bovine derived xenograft granules and 10% porcine collagen
|
|---|---|---|
|
Percent Fibrous Tissue and Marrow Space
|
60.7 percentage of marrow
Standard Deviation 17.8
|
55.2 percentage of marrow
Standard Deviation 12.7
|
Adverse Events
BioOss Collagen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
OSSIX™ Bone
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
Angela Palaiologou-Gallis , DDS., MS
UT Health San Antonio (UTHSA), San Antonio, Texas
Phone: 210-450 8736
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place