Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

The University of Texas System (UT)

Status: Completed

Conditions: Dental Implant

Treatments: Other: 3D R100 scanner; Other: Conventional Radiograph

Study type: Interventional

Funder types: Other

Identifiers

NCT06296459

20220556HU

Details and patient eligibility

About

A closed sinus augmentation is performed for dental implant placement.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

Low volume CBCT

Active Comparator group

Description:

Radiographic low volume cone beam computed tomography used to plan implant placement

Treatment:

Other: 3D R100 scanner

Standard periapical radiographs

Placebo Comparator group

Description:

Standard radiography used to plan implant placement

Treatment:

Other: Conventional Radiograph