An interventional study of cortical FDBA and Cancellous FDBA in Tooth Extraction, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 19 Years to 99 Years. Per ClinicalTrials.gov, last updated 2015-10-22.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)
Device: Cancellous FDBA
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Device: cortical FDBA
cortical mineralized freeze-dried bone allograft
CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
Histologic Percentage of Vital Bone Formation
Histologic percentage of vital bone formation in bone cores
Time frame: 18-20 weeks after grafting
| Milestone | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Histologic percentage of vital bone formation in bone cores
| percentage of vital bone | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) |
|---|---|---|
| Histologic Percentage of Vital Bone Formation | 12.98 (10.06 to 31.04) | 16.08 (12.12 to 30.25) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cancellous FDBA (LifeNet) | — | 0/20 (0%) | 0/20 (0%) |
| Cortical FDBA (LifeNet) | — | 0/20 (0%) | 0/20 (0%) |
patietns requring tooth extraction adn ridge preservation
| Age, Continuous(years) | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | Total |
|---|---|---|---|
| Mean | 53.4 (27 to 79) | 55.6 (31 to 69) | 54 (27 to 79) |
| Age, Categorical(Participants) | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 16 | 33 |
| >=65 years | 3 | 4 | 7 |
| Sex: Female, Male(Participants) | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 11 | 10 | 21 |
| Region of Enrollment(participants) | Cancellous FDBA (LifeNet) | Cortical FDBA (LifeNet) | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio