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Recruiting

NCT Number: NCT06507709

Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

The goal of this clinical study is to learn if cone beam computed tomography (CBCT) or 3-dimensional x-ray can help to let the investigator know if dental implant placement can be done after performing closed sinus surgery.

The study will look at the structure of your gum where the implant will be placed after performing the surgery using 3-D x-ray and compare that to how the structure of your gum looks 6 months later.

The 3-D imaging will happen after standard of care surgery to prepare your gum for an implant and then 6 months later to verify that the site is ready for the implant.

Recruiting

Interested in participating?

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Key information

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

Location status: Recruiting

Location contact

Charles A Powell, DDS, MS

PRINCIPAL_INVESTIGATOR

Charles Powell, DDS, MS

CONTACT

[email protected]

210-567-3593

About this study

While you are taking part in this study, participants will be asked to attend approximately two visits with the researchers or study staff. For research purposes, one visit is the surgical appointment and a postoperative visit at six months, these will likely be scheduled at standard of care visits.

If the participant elects a dental implant for tooth replacement, your sinus grafting will be performed, and the dental implant will be placed on the same appointment.

Study Procedures - as a participant in this research, you will undergo the following procedures:

  • Immediately upon completion of your sinus grafting and dental implant placement a three-dimensional x-ray will be taken in the Graduate Periodontics clinic.
  • At six months following your dental implant placement an additional three-dimensional x-ray will be taken in the Graduate Periodontics clinic.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability of participant to understand and the willingness to sign a written informed consent document.
  • English speaking.
  • Individuals who are normal healthy or have a diabetes diagnosis with a current HbA1c (glycated glucose)< 7.0.
  • Partially edentulous patients (18-85 years of age) requiring maxillary sinus augmentation for dental implant placement
  • At minimum 5mm of native bone below the maxillary sinus inferior border

Exclusion criteria

  • Maxillary sinus disease
  • Diabetes diagnosis with a current HbA1c > 7.1 or greater due to diabetes effect on bone metabolism
  • Pregnant or attempting to become pregnant
  • Having a disease that affects bone metabolism
  • Use of medications known to affect bone metabolism
  • Tobacco, cannabis or vaping use
  • Alcoholism or other recreational drugs

Treatment and study plan

Low volume CBCT

Procedure

3-D imaging used during dental practice

Other names: Cone Beam Computed Tomography

Primary outcomes

  1. Bone Volume change

    Time frame: Baseline to 6 months

    Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Powell, DDS, MS

CONTACT

[email protected]

210-567-3589

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Calcium Phosphosilicate

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2024
Registry last updated
Nov 12, 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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