Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
Purpose
A closed sinus augmentation is performed for dental implant placement.
Condition
- Dental Implant
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement. 2. At least 5mm of native bone below the maxillary sinus. 3. Nonsmokers. 4. If diabetic, current HbA1C <7.0 (less than or equal to 7.0)
Exclusion Criteria
- Maxillary sinus disease. 2. Pregnancy or attempting to become pregnant. 3. Diseases that affect bone metabolism. 4. Use of medications known to affect bone metabolism. 5. Tobacco use. 6. Alcoholism or recreational drug use. 7. Diabetic with HbA1C >7.0 (above 7.0)
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A 2 arm study using two methods of imaging in a participant
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Low volume CBCT |
Radiographic low volume cone beam computed tomography used to plan implant placement |
|
|
Placebo Comparator Standard periapical radiographs |
Standard radiography used to plan implant placement |
|
Recruiting Locations
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
Detailed Description
Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.