Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

Not Applicable

Recruiting

• Conditions: Dental Implant; Maxillary Sinus Floor Augmentation
• Interventions: Procedure: Low volume CBCT

• 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.

Study Timeline

• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-18
• Status Verified: 2024-10
• Study Start: 2024-10-08
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-04
• Study Completion: 2027-06

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

Arm && Interventions

Group	Intervention	Description
Closed sinus augmentation with Calcium Phosphosilicate Putty	Low volume CBCT	Use of CBCT immediately post-operatively after placement of Calcium Phosphosilicate Putty used as standard of care for closed sinus augmentation and at 6 months after surgery.

Primary Outcome Measures

Name	Time	Method
Bone Volume change	Baseline to 6 months	Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States