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Trial Outcomes & Findings for Bone Graft Particle Size on Bone Vitality and Volume (NCT NCT04778709)

NCT ID: NCT04778709

Last Updated: 2023-12-01

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

After surgery, 8 months, 1 year

Results posted on

2023-12-01

Participant Flow

Unit of analysis: tooth sites

Participant milestones

Participant milestones
Measure
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 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.
Bone Graft B
Bone Graft B: 100% large particle cancellous allograft 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.
Overall Study
STARTED
2 4
2 4
Overall Study
COMPLETED
0 0
0 0
Overall Study
NOT COMPLETED
2 4
2 4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bone Graft Particle Size on Bone Vitality and Volume

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Bone Graft A
n=4 Tooth Sites
Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft 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.
Bone Graft B
n=4 Tooth Sites
Bone Graft B: 100% large particle cancellous allograft 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.
Total
n=8 Tooth Sites
Total of all reporting groups
Age, Customized
18-25 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Customized
26-35 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Customized
36-45 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Customized
46-55 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Customized
56-65 years
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Hispanic
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-Hispanic White
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: After surgery, 8 months, 1 year

Population: Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study.

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

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After surgery, 8 months, 1 year

Population: Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study.

Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of residual bone graft material

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: After surgery, 8 months, 1 year

Population: Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study.

Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After surgery, 8 months, 1 year

Population: Data were not collected. The original PI who is no longer at the institution, the sponsor of this research study, Zimmer Biomet, along with the current PI has decided to close enrollment to the study and to early terminate the study.

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

Outcome measures

Outcome data not reported

Adverse Events

Bone Graft A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Bone Graft B

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aikaterini Georgantza

NYU College of Dentistry

Phone: 212-998-9986

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place