Bone Graft Particle Size on Bone Vitality and Volume

NCT04778709 | Terminated Results FDA Device

• 1 other identifier: 19-00996
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Bilateral Sinus Pneumatization; Posterior Maxillary Ridge Atrophy Due to Extraction

Keywords

Sinus floor augmentation; Bone graft; Allograft; Dental implants; Maxillary sinus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Bone Volume Stability

  After surgery, 8 months, 1 year

Study Arms (2)

Bone Graft A

EXPERIMENTAL

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

Bone Graft B

ACTIVE COMPARATOR

Bone Graft B: 100% large particle cancellous allograft

Device: Puros allograft

Interventions

Puros allograft DEVICE

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.

Bone Graft A; Bone Graft B

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU College of Dentistry: lead

Study Sites (1)

Department of Periodontology and Implant Dentistry

New York, New York, 10010, United States

Location

Results Point of Contact

• Title: Aikaterini Georgantza
• Organization: NYU College of Dentistry

ag4222@nyu.edu

212-998-9986

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

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

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: March 3, 2021
• Study Start: November 13, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 1, 2023
• Results First Posted: December 1, 2023

Record last verified: 2023-11

Locations

US (1)