Bone Graft Particle Size on Bone Vitality and Volume

Sponsor

NYU College of Dentistry (Other)

Overall Status

Recruiting

CT.gov ID

NCT04778709

Collaborator

(none)

Enrollment

Location

Arms

33.6

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bilateral Sinus Pneumatization Posterior Maxillary Ridge Atrophy Due to Extraction	Device: Puros allograft	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 13, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Quality of bone [After surgery, 8 months, 1 year]
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
Quality of bone [After surgery, 8 months, 1 year]
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material
Quality of bone [After surgery, 8 months, 1 year]
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any

Secondary Outcome Measures

Bone volume stability [After surgery, 8 months, 1 year]
Assessment of bone volume stability through CBCT analysis comparing it from the time of placement, 8 months post-grafting and 1 year post-implantation

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Periodontology and Implant Dentistry	New York	New York	United States	10010

Sponsors and Collaborators

NYU College of Dentistry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Edgard El Chaar, Clinical Associate Professor, NYU College of Dentistry

ClinicalTrials.gov Identifier:

NCT04778709

Other Study ID Numbers:

19-00996

First Posted:

Mar 3, 2021

Last Update Posted:

Mar 3, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Edgard El Chaar, Clinical Associate Professor, NYU College of Dentistry

Sinus floor augmentation

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Mar 3, 2021