An interventional study of Puros allograft in Bilateral Sinus Pneumatization and Posterior Maxillary Ridge Atrophy Due to Extraction, sponsored by NYU College of Dentistry. Terminated at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by NYU College of Dentistry · Not applicable, Interventional, and Treatment
To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.
The proposed study is a Randomized, single-masked, split-mouth, single center study.
About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.
At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:
At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.
NYU College of Dentistry is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft
Device: Puros allograft
Bone Graft B: 100% large particle cancellous allograft
Device: Puros allograft
Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus. Each subject will receive the following bone allograft material: Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone.
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent vital bone formation, percent of inflammatory tissue if any
Time frame: After surgery, 8 months, 1 year
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material
Time frame: After surgery, 8 months, 1 year
Quality of Bone
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any
Time frame: After surgery, 8 months, 1 year
Bone Volume Stability
Assessment of bone volume stability through CBCT analysis comparing it from the time of placement, 8 months post-grafting and 1 year post-implantation
Time frame: After surgery, 8 months, 1 year
| Milestone | Bone Graft A | Bone Graft B |
|---|---|---|
| Started | 2 | 2 |
| Completed | 0 | 0 |
| Not completed | 2 | 2 |
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent vital bone formation, percent of inflammatory tissue if any
No measurements were reported for this outcome.
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material
No measurements were reported for this outcome.
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any
No measurements were reported for this outcome.
Assessment of bone volume stability through CBCT analysis comparing it from the time of placement, 8 months post-grafting and 1 year post-implantation
No measurements were reported for this outcome.
Collected over 14 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bone Graft A | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Bone Graft B | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Customized(Participants) | Bone Graft A | Bone Graft B | Total |
|---|---|---|---|
| 18-25 years | 0 | 0 | 0 |
| 26-35 years | 0 | 0 | 0 |
| 36-45 years | 0 | 0 | 0 |
| 46-55 years | 0 | 0 | 0 |
| 56-65 years | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Bone Graft A | Bone Graft B | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Bone Graft A | Bone Graft B | Total |
|---|---|---|---|
| Hispanic | 0 | 1 | 1 |
| Non-Hispanic White | 2 | 1 | 3 |
| Region of Enrollment(participants) | Bone Graft A | Bone Graft B | Total |
|---|---|---|---|
| United States | 2 | 2 | 4 |
Documents are hosted by the registry — open the source record to download them.
Ran from Nov 2020 to primary completion in Feb 2022, 14 months.
Results were first posted in Dec 2023, 1 year 10 months after primary completion.
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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NYU College of Dentistry