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Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06296459
Enrollment
25
Registered
2024-03-06
Start date
2022-09-21
Completion date
2024-12-19
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant

Keywords

Cone beam computed tomography, Sinus anatomy, Dental implant placement

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.

Interventions

OTHER3D R100 scanner

A cone beam computed tomography used for planning of implant surgery

OTHERConventional Radiograph

Imaging used as standard of care to plan for implant surgery

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A 2 arm study using two methods of imaging in a participant

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Dimensional Change in augmentation at 8mmBaseline immediately postoperatively and at 6 monthsDetermine 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.
Dimensional Change in augmentation at 10mmBaseline immediately postoperatively and at 6 monthsDetermine 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 12mmBaseline immediately postoperatively and at 6 monthsDetermine 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026