Clinical trial NCT06507709: Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
Official title: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Calcium Phosphosilicate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Maxillary Sinus Floor Augmentation
Keywords: Cone beam computed tomography
Calcium Phosphosilicate putty
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series single group with no control
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bone Volume change
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: The University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Charles Powell, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: