Maxillary Sinus Floor Augmentation
Conditions
Keywords
Maxillary Sinus/surgery, Bone Substitutes, Radiography, Panoramic
Brief summary
The sinus infiltration technique for sinus floor elevation has been used successfully when a reduced vertical height is available in the posterior maxilla. However, the effect of the different graft material on the volume and on the quality of new bone formed has not been fully investigated. The aim of this study is to evaluate the clinical and histological effect of a test material, lyophilized equine bone (Bio-gen®), compared with control material, deproteinized bovine bone (Endobon®), in the sinus lift techniques with lateral approach.
Interventions
DEVICEsinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)
DEVICESinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* bilateral atrophy of the maxilla; * bone ridge \<= 6mm
Exclusion criteria
* severe systemic diseas (ASA III -IV) bisphosphonate therapy or a history of up to 3 years history of radiation therapy to neck and head area sinusitis pregnancy subjects not able to consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Histomorphometric Evaluation of New Bone Formation. | 6 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lyophilized Equine Bone Allograft Sinus Lift with Lyophilized Equine Bone Allograft
sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy) | 8 |
| Deproteinized Bovine Bone Allograft Sinus lift with deproteinized bovine bone allograft
Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy) | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Deproteinized Bovine Bone Allograft | Lyophilized Equine Bone Allograft | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 6 | 51 years STANDARD_DEVIATION 6 | 51 years STANDARD_DEVIATION 6 |
| Region of Enrollment Italy | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Histomorphometric Evaluation of New Bone Formation.
Time frame: 6 months
Population: Caucasion patients aged ≥ 25 years with at least one atrophic posterior maxilla (distally from first bicuspid teeth) with a residual crest height ≤4 mm who need sinus lift augmentation for dental implant placement were eligible for the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lyophilized Equine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | newly formed bone | 22.20 percentage of millimeters | Standard Deviation 7.18 |
| Lyophilized Equine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | marrow spaces | 50.77 percentage of millimeters | Standard Deviation 7.59 |
| Lyophilized Equine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | residual graft material | 27 percentage of millimeters | Standard Deviation 6.75 |
| Deproteinized Bovine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | newly formed bone | 22.84 percentage of millimeters | Standard Deviation 7.34 |
| Deproteinized Bovine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | marrow spaces | 46.20 percentage of millimeters | Standard Deviation 14.3 |
| Deproteinized Bovine Bone Allograft | Histomorphometric Evaluation of New Bone Formation. | residual graft material | 30.94 percentage of millimeters | Standard Deviation 10.2 |