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Clinical Trials/NCT06296459
NCT06296459
Completed
Not Applicable

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

The University of Texas Health Science Center at San Antonio1 site in 1 country25 target enrollmentSeptember 21, 2022
ConditionsDental Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
25
Locations
1
Primary Endpoint
Dimensional Change in augmentation at 10mm
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2022
End Date
December 19, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Maxillary sinus disease.
  • Pregnancy or attempting to become pregnant.
  • Diseases that affect bone metabolism.
  • Use of medications known to affect bone metabolism.
  • Tobacco use.
  • Alcoholism or recreational drug use.
  • Diabetic with HbA1C \>7.0 (above 7.0)

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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