Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

January 31, 2025 updated by: The University of Texas Health Science Center at San Antonio
A closed sinus augmentation is performed for dental implant placement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who are diagnosed as needing sinus augmentation by a closed approach for dental implant placement will be recruited. A cone beam computed tomography (CBCT) study is the standard of care prior to dental implant placement. However, following closed sinus augmentation nothing is known as to the extent of augmentation in the medial to lateral (cross-sectional) dimension. Patients will have a low volume CBCT taken immediately postsurgically, and again at the six-month postoperative visit to determine the dimensional changes in the augmentation. These images will be compared to standard periapical radiographs at the same time points.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement.
  2. At least 5mm of native bone below the maxillary sinus.
  3. Nonsmokers.
  4. If diabetic, current HbA1C <7.0 (less than or equal to 7.0)

Exclusion Criteria:

  1. Maxillary sinus disease.
  2. Pregnancy or attempting to become pregnant.
  3. Diseases that affect bone metabolism.
  4. Use of medications known to affect bone metabolism.
  5. Tobacco use.
  6. Alcoholism or recreational drug use.
  7. Diabetic with HbA1C >7.0 (above 7.0)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low volume CBCT
Radiographic low volume cone beam computed tomography used to plan implant placement
Other: 3D R100 scanner
A cone beam computed tomography used for planning of implant surgery
Other Names:
  • Veraviewpocs
Placebo Comparator: Standard periapical radiographs
Standard radiography used to plan implant placement
Other: Conventional Radiograph
Imaging used as standard of care to plan for implant surgery
Other Names:
  • Standard Periapical Radiograph

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dimensional Change in augmentation at 8mm
Time Frame: Baseline immediately postoperatively and at 6 months
Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 8mm from alveolar crest.
Baseline immediately postoperatively and at 6 months
Dimensional Change in augmentation at 10mm
Time Frame: Baseline immediately postoperatively and at 6 months
Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 10 mm from alveolar crest.
Baseline immediately postoperatively and at 6 months
Dimensional Change in augmentation at 12mm
Time Frame: Baseline immediately postoperatively and at 6 months
Determine the morphologic changes to maxillary sinus anatomy three dimensionally when a closed sinus augmentation is performed for dental implant placement at 12 mm from alveolar crest.
Baseline immediately postoperatively and at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Charles Powell, DDS, MS, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

December 19, 2024

Study Completion (Actual)

December 19, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20220556HU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All deidentified participant data will be shared with colleagues

IPD Sharing Time Frame

After study completion in a peer review journal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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