Inadequate Bone Height in Maxillary Posterior Area
Conditions
Keywords
Histomorphometric Analysis, New bone Formation, Sinus Augmentation, Bone Graft Materials
Brief summary
The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.
Detailed description
The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is \< 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation \> 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.
Interventions
PROCEDURESinus augmentation
DRUGEquimatrix
Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)
DRUGOSSIF-i sem
OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2
DRUGBio-oss
Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)
Sponsors
American Regent, Inc.
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Over 18 years old who are able to read and sign written consent form. 2. Patient who has good oral hygiene (Full-mouth plaque score \<25%). 3. Subject would be available for study monitoring. 4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous. 5. Delayed implant placement approximately 8 months following sinus grafting.
Exclusion criteria
A medical history that will complicate the outcome of the study such as: 1. alcohol, drug dependency, 2. signs or symptoms of maxillary sinus disease, 3. current smoker, 4. history of head and neck radiation treatment, 5. poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Vital Bone in a Total Amount of a Bone Specimen | 24months | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | 24months | Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis. |
Countries
United States
Participant flow
Pre-assignment details
The enrolled patients had either unilateral or bilateral maxillary sinus requiring maxillary sinus graft. For patients with bilateral sinus, each maxillary sinus was randomly assigned different treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Sinus Augmentation Using Bio-oss Sinus augmentation using Bio-oss
Sinus augmentation
Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc) | 9 |
| Sinus Augmentation Using Bio-oss Sinus augmentation using Bio-oss
Sinus augmentation
Bio-oss: Bio-oss small granules cancellous 0.25-1mm, approximately 2.5g (5cc) | 9 |
| Sinus Augmentation Using Equimatrix Sinus augmentation using Equimatrix
Sinus augmentation
Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc) | 9 |
| Sinus Augmentation Using Equimatrix Sinus augmentation using Equimatrix
Sinus augmentation
Equimatrix: Equimatrix cancellous particle size 0.2-1mm approximately 2.5g (5cc) | 9 |
| Sinus Augmentation Using OSSIF-i Sem Sinus augmentation using OSSIF-i sem
Sinus augmentation
OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc | 10 |
| Sinus Augmentation Using OSSIF-i Sem Sinus augmentation using OSSIF-i sem
Sinus augmentation
OSSIF-i sem: OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 5cc | 10 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Sinus Augmentation Using Bio-oss | Sinus Augmentation Using Equimatrix | Sinus Augmentation Using OSSIF-i Sem | Total |
|---|---|---|---|---|
| Age, Continuous | 60.9 years | 65.6 years | 57.9 years | 61.5 years |
| Age, Customized >=65 years | 4 participants | 5 participants | 4 participants | 10 participants |
| Age, Customized Between 18 and 65 years | 5 participants | 4 participants | 6 participants | 11 participants |
| Region of Enrollment United States | 9 participants | 9 participants | 10 participants | 21 participants |
| Sex/Gender, Customized Female | 5 participants | 3 participants | 5 participants | 11 participants |
| Sex/Gender, Customized Male | 4 participants | 6 participants | 5 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 11 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 10 |
Outcome results
Primary
The Percentage of Vital Bone in a Total Amount of a Bone Specimen
Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.
Time frame: 24months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sinus Augmentation Using Bio-oss | The Percentage of Vital Bone in a Total Amount of a Bone Specimen | 10.9 percentage of vital bone | Standard Deviation 8.9 |
| Sinus Augmentation Using Equimatrix | The Percentage of Vital Bone in a Total Amount of a Bone Specimen | 9.1 percentage of vital bone | Standard Deviation 5.9 |
| Sinus Augmentation Using OSSIF-i Sem | The Percentage of Vital Bone in a Total Amount of a Bone Specimen | 32.0 percentage of vital bone | Standard Deviation 12.4 |
Secondary
The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.
Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.
Time frame: 24months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sinus Augmentation Using Bio-oss | The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | 34.3 percentage of residual bone materials | Standard Deviation 12.1 |
| Sinus Augmentation Using Equimatrix | The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | 38.9 percentage of residual bone materials | Standard Deviation 5.3 |
| Sinus Augmentation Using OSSIF-i Sem | The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone. | 5.5 percentage of residual bone materials | Standard Deviation 5.7 |