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Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

Not Applicable
Recruiting
Conditions
Dental Implant
Maxillary Sinus Floor Augmentation
Registration Number
NCT06507709
Lead Sponsor
The University of Texas Health Science Center at San Antonio
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
25
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Bone Volume changeBaseline to 6 months

Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Charles Powell, DDS, MS
Contact
210-567-3593
powellc2@uthscsa.edu
Charles A Powell, DDS, MS
Principal Investigator
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