Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery. The study will look at the structure of your gum where the implant will be placed after performi
| Condition(s) | Dental Implant, Maxillary Sinus Floor Augmentation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery. The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later. The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant. |
| Who can participate | Inclusion Criteria: 1. Ability of participant to understand and the willingness to sign a written informed consent document. 2. English speaking. 3. Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose)\< 7.0. 4. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement 5. At minimum 5mm of native bone below the maxillary sinus inferior border Exclusion Criteria: 1. Maxillary sinus disease 2. Diabetes diagnosis with a current HbA1c \> 7.1 or greater due to diabetes effect on bone metabolism 3. Pregnant or attempting to become pregnant 4. Having a disease that affects bone metabolism 5. Use of medications known to affect bone metabolism 6. Tobacco, cannabis or vaping use 7. Alcohol |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | The University of Texas Health Science Center at San Antonio |
| Locations | San Antonio, Texas, United States |
| Start date | 2024-10-08 |
| NCT ID | NCT06507709 |
| Official listing | https://clinicaltrials.gov/study/NCT06507709 |