Dental Implant, Maxillary Sinus Floor Augmentation
Conditions
Keywords
Cone beam computed tomography, Calcium Phosphosilicate putty
Brief 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.
Detailed description
While you are taking part in this study, participants will be asked to attend approximately two visits with the researchers or study staff. For research purposes, one visit is the surgical appointment and a postoperative visit at six months, these will likely be scheduled at standard of care visits. If the participant elects a dental implant for tooth replacement, your sinus grafting will be performed, and the dental implant will be placed on the same appointment. Study Procedures - as a participant in this research, you will undergo the following procedures: 1. Immediately upon completion of your sinus grafting and dental implant placement a three-dimensional x-ray will be taken in the Graduate Periodontics clinic. 2. At six months following your dental implant placement an additional three-dimensional x-ray will be taken in the Graduate Periodontics clinic.
Interventions
PROCEDURELow volume CBCT
3-D imaging used during dental practice
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Case series single group with no control
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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. Alcoholism or other recreational drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Volume change | Baseline to 6 months | Bone volume changes will be reported as a percentage, with mean, median, and standard deviation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCharles Powell, DDS, MS
The University of Texas Health Science Center at San Antonio
Outcome results
None listed