Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

NCT06507709 | Recruiting

• 1 other identifier: STUDY00000739
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Maxillary Sinus Floor Augmentation

Keywords

Cone beam computed tomography; Calcium Phosphosilicate putty

Outcome Measures

Primary Outcomes (1)

• Bone Volume change

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

  Baseline to 6 months

Study Arms (1)

Closed sinus augmentation with Calcium Phosphosilicate Putty

EXPERIMENTAL

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.

Procedure: Low volume CBCT

Interventions

Low volume CBCT PROCEDURE

3-D imaging used during dental practice

Also known as: Cone Beam Computed Tomography

Closed sinus augmentation with Calcium Phosphosilicate Putty

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability of participant to understand and the willingness to sign a written informed consent document.
• English speaking.
• Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose)\< 7.0.
• Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
• At minimum 5mm of native bone below the maxillary sinus inferior border

You may not qualify if:

• Maxillary sinus disease
• Diabetes diagnosis with a current HbA1c \> 7.1 or greater due to diabetes effect on bone metabolism
• Pregnant or attempting to become pregnant
• Having a disease that affects bone metabolism
• Use of medications known to affect bone metabolism
• Tobacco, cannabis or vaping use
• Alcoholism or other recreational drugs

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Study Officials

• Charles Powell, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Powell, DDS, MS

CONTACT

210-567-3589; powellc2@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case series single group with no control

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available in a journal at study end at the time of publication.

Locations

US (1)