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Original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI have decided to close enrollment to the study and to early terminate the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone Graft A | Experimental | Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft |
|
| Bone Graft B | Active Comparator | Bone Graft B: 100% large particle cancellous allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Puros allograft | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | After surgery, 8 months, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After surgery, 8 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Implant Dentistry | New York | New York | 10010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Graft A | Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft 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. |
| FG001 | Bone Graft B | Bone Graft B: 100% large particle cancellous allograft 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Graft A | Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study. | Posted | After surgery, 8 months, 1 year |
|
14 months
Data on all serious and non-serious Adverse Events experienced by participants were collected, irrespective of the event's relation to the tooth site.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bone Graft A | Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aikaterini Georgantza | NYU College of Dentistry | 212-998-9986 | ag4222@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2021 | Jan 5, 2023 | Prot_SAP_000.pdf |
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Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.
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CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.
|
| BG001 | Bone Graft B | Bone Graft B: 100% large particle cancellous allograft 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. |
| BG002 | Total | Total of all reporting groups |
| Tooth Sites |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
|
| OG001 | Bone Graft B | Bone Graft B: 100% large particle cancellous allograft 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. |
|
| Primary | 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 | Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study. | Posted | After surgery, 8 months, 1 year |
|
|
| Primary | 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 | Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study. | Posted | After surgery, 8 months, 1 year |
|
|
| Secondary | 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 | Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study. | Posted | After surgery, 8 months, 1 year |
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| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Bone Graft B | Bone Graft B: 100% large particle cancellous allograft 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. | 0 | 2 | 0 | 2 | 0 | 2 |
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