An interventional study of allograft alone and allograft with autograft in Dental Alveolus and Oral Surgical Procedures, Preprosthetic, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-02.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
When a tooth or teeth are extracted, a defect in the bony ridge often forms. This loss of bone may make it impossible to place a dental implant. Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
Guided bone regeneration procedures are used to re-establish a bone dimension sufficient to place a dental implant. The primary objective of the study is to determine whether there is any difference in the gain of horizontal alveolar ridge width following guided bone regeneration surgery using a combined autogenous/allogenic particulate bone graft versus a particulate allograft alone. Autogenous bone has historically been considered the gold standard for alveolar ridge grafting; however, other materials including allografts and xenografts have also been used with excellent results. This study evaluates the potential benefits, or lack thereof, for using a combined autogenous/allograft approach versus an allograft alone. The investigators will clinically evaluate the efficacy of this technique and determine the difference in bone formation between groups following healing at 5 months by observing bone growth relative to heads of the tenting screws placed horizontally in the locations of greatest defect in the alveolar ridge. A biopsy of the healed site will be taken at the time of implant placement. The null hypothesis is that there will be no difference in the amount of horizontal ridge width gain at 5 months post-grafting between the two different grafting materials (allograft alone versus allograft combined with autogenous bone). Furthermore, the null hypothesis is that histologically, the combination graft (MinerOss®/particulate autograft) will have a similar percentage of vital bone present at 5 months compared to the allograft-alone group (MinerOss®).
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:
guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)
Device: allograft alone
guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)
Device: allograft with autograft
use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
Gain in Horizontal Ridge Dimension
Time frame: 5 months after surgery
Percentage of New Bone Formation (Histologic)
Time frame: 5 months after surgery
| Milestone | Allograft Alone | Allograft Combined With Autograft |
|---|---|---|
| Started | 14 | 13 |
| Completed | 12 | 12 |
| Not completed | 2 | 1 |
| gain in ridge width (mm) | Allograft Alone | Allograft Combined With Autograft |
|---|---|---|
| Gain in Horizontal Ridge Dimension | 3.33 ± 0.83 | 3.09 ± 0.63 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Allograft Alone | — | 0/14 (0%) | 0/14 (0%) |
| Allograft Combined With Autograft | — | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Allograft Alone | Allograft Combined With Autograft | Total |
|---|---|---|---|
| Mean | 49.5 ± 11.8 | 47.5 ± 14.5 | 48.9 ± 12.6 |
| Age, Categorical(Participants) | Allograft Alone | Allograft Combined With Autograft | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 11 | 23 |
| >=65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Allograft Alone | Allograft Combined With Autograft | Total |
|---|---|---|---|
| Female | 12 | 11 | 23 |
| Male | 2 | 2 | 4 |
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