Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778709
Status:
TERMINATED
Last Update Posted:
2023-12-01
First Post:
2021-01-30
Brief Title:
Bone Graft Particle Size on Bone Vitality and Volume
Sponsor:
NYU College of Dentistry
Organization:
NYU College of Dentistry
Study Overview
Official Title:
A Randomized Split Mouth Study of the Effects of Bone Graft Particle Size on Bone Vitality and Bone Volume Outcomes in Subjects Undergoing Sinus Augmentation for the Placement of Dental Implants
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 11 into one of the following bone grafts to either the right or left side of the mouth
Bone graft A A mixture of 25 small-particle cortical allograft 25 large-particle cortical allograft 25 small-particle cancellous allograft and 25 large-particle cancellous allograft is used for one sinus N10
Bone graft B 100 large particle cancellous allograft for the contralateral sinus N10 Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus
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
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 11 into one of the following bone grafts to either the right or left side of the mouth
Bone graft A A mixture of 25 small-particle cortical allograft 25 large-particle cortical allograft 25 small-particle cancellous allograft and 25 large-particle cancellous allograft is used for one sinus N10
Bone graft B 100 large particle cancellous allograft for the contralateral sinus N10 Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None