Lateral Window Sinus Augmentation
Conditions
Keywords
Bone graft, Lateral window approach, Sinus augmentation, Volumetric change
Brief summary
The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.
Detailed description
This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation. Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.
Interventions
DEVICEAllograft bone alone
The subject will receive an allograft as graft material of choice for sinus augmentation
DEVICEAllograft and xenograft mixture
The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult patients ≥ 18 years old 2. In need of sinus augmentation utilizing lateral window sinus technique 3. Presence of bone height of \< 8 mm 4. Patient has good oral hygiene (\<40% plaque score) 5. Periodontally stable 6. Willingness to fulfill all study requirements
Exclusion criteria
1. Currently smoking \> 10 cigarettes / day 2. Pregnant, expecting to become pregnant or lactating mothers 3. Uncontrolled Diabetes Mellitus (HbA1c \>7) 4. Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections) 5. Current use of oral bisphosphonates 6. History of IV bisphosphonates use 7. Poor oral hygiene (plaque score \>40% based on O'Leary plaque score) 8. Unmanageable Sinus perforations 9. Significant pathology in the region of interest that may compromise the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Graft volumetric stability change | CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material | CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histomorphometric analysis | After 6 months of sinus augmentation procedure when the implant is placed | Identify histological differences between two groups of graft material in sinus augmentation procedure |
Countries
United States
Outcome results
None listed