Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Completed
CT.gov ID
NCT01588444
Collaborator
(none)
40
1
2
21
1.9
Study Details
Study Description
Brief Summary
The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Study Start Date
:
Oct 1, 2010
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cancellous FDBA (LifeNet) grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) |
Device: Cancellous FDBA
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
|
| Experimental: cortical FDBA (LifeNet) CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) |
Device: cortical FDBA
cortical mineralized freeze-dried bone allograft
|
Outcome Measures
Primary Outcome Measures
- Histologic Percentage of Vital Bone Formation [18-20 weeks after grafting]
Histologic percentage of vital bone formation in bone cores
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- single rooted tooth requiring extraction with future dental implant placement
Exclusion Criteria:
- smoking > 10 cigarettes per day poorly controlled diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UT Health Science Center Dental School | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- The University of Texas Health Science Center at San Antonio
Investigators
- Principal Investigator: Brian L Mealey, DDS, MS, The University of Texas Health Science Center at San Antonio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01588444
Other Study ID Numbers:
- HSC20110039H
First Posted:
May 1, 2012
Last Update Posted:
Oct 22, 2015
Last Verified:
Oct 1, 2015
Keywords provided by The University of Texas Health Science Center at San Antonio
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) |
|---|---|---|
| Arm/Group Description | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft |
| Period Title: Overall Study | ||
| STARTED | 20 | 20 |
| COMPLETED | 20 | 20 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | Total |
|---|---|---|---|
| Arm/Group Description | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft | Total of all reporting groups |
| Overall Participants | 20 | 20 | 40 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
53.4
|
55.6
|
54
|
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
17
85%
|
16
80%
|
33
82.5%
|
| >=65 years |
3
15%
|
4
20%
|
7
17.5%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
45%
|
10
50%
|
19
47.5%
|
| Male |
11
55%
|
10
50%
|
21
52.5%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
20
100%
|
20
100%
|
40
100%
|
Outcome Measures
| Title | Histologic Percentage of Vital Bone Formation |
|---|---|
| Description | Histologic percentage of vital bone formation in bone cores |
| Time Frame | 18-20 weeks after grafting |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) |
|---|---|---|
| Arm/Group Description | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft |
| Measure Participants | 20 | 20 |
| Median (Inter-Quartile Range) [percentage of vital bone] |
12.98
|
16.08
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | ||
| Arm/Group Description | grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) | CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft | ||
All Cause Mortality |
||||
| Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/20 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE 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. Brian Mealey |
|---|---|
| Organization | UT Health Sci Ctr San Antonio |
| Phone | 210-567-3567 |
| mealey@uthscsa.edu |
Responsible Party:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01588444
Other Study ID Numbers:
- HSC20110039H
First Posted:
May 1, 2012
Last Update Posted:
Oct 22, 2015
Last Verified:
Oct 1, 2015