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

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.

Study Overview

• Status: Terminated
• Conditions: Bilateral Sinus Pneumatization; Posterior Maxillary Ridge Atrophy Due to Extraction
• Intervention / Treatment: Device: Puros allograft

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edgard El Chaar, DDS, MS; Phone Number: 212 998-9986; Email: ese1@nyu.edu
• Study Contact Backup: Name: Aikaterini Georgantza, DDS; Phone Number: 212-998-9730; Email: ag4222@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Department of Periodontology and Implant Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Good physical health
• Capable of maintaining good oral hygiene
• Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
• Capable and willing to give informed consent

Exclusion Criteria:

• The presence of underlying medical conditions that may pose an undue risk for sinus surgery
• Patients with untreated oral infections
• Pregnant and lactating females
• Individuals who have the habit of smoking and/or tobacco chewing
• Patients not willing to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Active Comparator: Bone Graft B; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU College of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Dental implants; Allograft; Sinus floor augmentation; Bone graft; Maxillary sinus
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 19-00996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes