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Bone Graft Particle Size on Bone Vitality and Volume

NCT04778709 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-12-01

Study results available
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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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • NYU College of Dentistry

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04778709 on ClinicalTrials.gov