Bilateral Sinus Pneumatization, Posterior Maxillary Ridge Atrophy Due to Extraction
Conditions
Keywords
Sinus floor augmentation, Bone graft, Allograft, Dental implants, Maxillary sinus
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.
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.
Interventions
DEVICEPuros 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
NYU College of Dentistry
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 4 |
| 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. | 2 |
| 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. | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | Bone Graft A | Bone Graft B | Total |
|---|---|---|---|
| Age, Customized 18-25 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 26-35 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 36-45 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 46-55 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 56-65 years | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
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
Time frame: 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.
Primary
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
Time frame: 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.
Primary
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
Time frame: 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.
Secondary
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
Time frame: 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.