NCT04778709

Bone Graft Particle Size on Bone Vitality and Volume

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: NYU College of Dentistry · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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 1:1 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 (N=10) * Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) 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.

Conditions

• Bilateral Sinus Pneumatization
• Posterior Maxillary Ridge Atrophy Due to Extraction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-11-13
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2021-03-03
• Last updated: 2023-12-01
• Results posted: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study