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OpenTrials
Completed

NCT Number: NCT06296459

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation

A closed sinus augmentation is performed for dental implant placement.

Completed

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Key information

Conditions

Dental Implant

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3D R100 scanner

Other

A cone beam computed tomography used for planning of implant surgery

Other names: Veraviewpocs

Conventional Radiograph

Other

Imaging used as standard of care to plan for implant surgery

Other names: Standard Periapical Radiograph

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2024
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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