Trial Outcomes & Findings for A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction (NCT NCT02844569)
NCT ID: NCT02844569
Last Updated: 2019-02-06
Results Overview
The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
6 months
Results posted on
2019-02-06
Participant Flow
Participant milestones
| Measure |
Test
Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
|
Control
Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction
Baseline characteristics by cohort
| Measure |
Test
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
|
Control
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
n=5 Participants
|
56.4 years
n=7 Participants
|
50.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.
Outcome measures
| Measure |
Test
n=10 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
|
Control
n=8 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
|
|---|---|---|
|
Change in Buccal Plate Thickness From Baseline to Month 6
|
1.85 mm
Standard Deviation 0.72
|
1.25 mm
Standard Deviation 0.45
|
PRIMARY outcome
Timeframe: 6 monthsThe soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner.
Outcome measures
| Measure |
Test
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
|
Control
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
|
|---|---|---|
|
Change in Buccal Soft Tissue Volume Between Baseline and 6 Months
|
68.6 mm^3
Standard Deviation 25.4
|
87.6 mm^3
Standard Deviation 39.1
|
PRIMARY outcome
Timeframe: 6 monthsThe buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data.
Outcome measures
| Measure |
Test
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
3D-collagen matrix: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
|
Control
n=12 Participants
Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).
Xenograft bone substitute: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressing: Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
|
|---|---|---|
|
Change in Buccal Bone Volume Between Baseline and 6 Months
|
72.6 mm^3
Standard Deviation 30.7
|
60.9 mm^3
Standard Deviation 37.3
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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. Thiago Morelli
University of North Carolina at Chapel Hill
Phone: 919-537-3727
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place