Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

NCT06296459 | Completed

• 1 other identifier: 20220556HU
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A closed sinus augmentation is performed for dental implant placement.

Conditions

Dental Implant

Keywords

Cone beam computed tomography; Sinus anatomy; Dental implant placement

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Low volume CBCT

ACTIVE COMPARATOR

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

Other: 3D R100 scanner

Standard periapical radiographs

PLACEBO COMPARATOR

Standard radiography used to plan implant placement

Other: Conventional Radiograph

Interventions

3D R100 scanner OTHER

A cone beam computed tomography used for planning of implant surgery

Also known as: Veraviewpocs

Low volume CBCT

Conventional Radiograph OTHER

Imaging used as standard of care to plan for implant surgery

Also known as: Standard Periapical Radiograph

Standard periapical radiographs

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Study Officials

• Charles Powell, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 6, 2024
• Study Start: September 21, 2022
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion in a peer review journal

Locations

US (1)