Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

Not Applicable

Completed

• Conditions: Dental Implant
• Interventions: Other: 3D R100 scanner; Other: Conventional Radiograph

• Registration Number: NCT06296459
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

A closed sinus augmentation is performed for dental implant placement.

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 Timeline

• Study Start: 2022-09-21
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Primary Completion: 2024-12-19
• Study Completion: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low volume CBCT	3D R100 scanner	Radiographic low volume cone beam computed tomography used to plan implant placement
Standard periapical radiographs	Conventional Radiograph	Standard radiography used to plan implant placement

Primary Outcome Measures

Name	Time	Method
Dimensional Change in augmentation at 10mm	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.
Dimensional Change in augmentation at 12mm	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.
Dimensional Change in augmentation at 8mm	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.

Trial Locations

Locations (1)

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