Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

Dental Implant Clinical Trial

Official title:

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296459
• Other study ID #: 20220556HU
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Charles Powell, DDS, MS
• Phone: 210-567-3593
• Email: powellc2[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A closed sinus augmentation is performed for dental implant placement.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dental Implant

Intervention

Other:
• 3D R100 scanner
A cone beam computed tomography used for planning of implant surgery
• Conventional Radiograph
Imaging used as standard of care to plan for implant surgery

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dimensional Change in augmentation at 8mm	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
Primary	Dimensional Change in augmentation at 10mm	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
Primary	Dimensional Change in augmentation at 12mm	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