Closed Sinus Augmentation With a Calcium Phosphosilicate Putty

NCT ID: NCT06507709

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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:

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

Conditions

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Dental Implant Maxillary Sinus Floor Augmentation

Keywords

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Cone beam computed tomography Calcium Phosphosilicate putty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case series single group with no control
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Closed sinus augmentation with Calcium Phosphosilicate Putty

Use of CBCT immediately post-operatively after placement of Calcium Phosphosilicate Putty used as standard of care for closed sinus augmentation and at 6 months after surgery.

Group Type EXPERIMENTAL

Low volume CBCT

Intervention Type PROCEDURE

3-D imaging used during dental practice

Interventions

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Low volume CBCT

3-D imaging used during dental practice

Intervention Type PROCEDURE

Other Intervention Names

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Cone Beam Computed Tomography

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Maxillary sinus disease
2. Diabetes diagnosis with a current HbA1c \> 7.1 or greater due to diabetes effect on bone metabolism
3. Pregnant or attempting to become pregnant
4. Having a disease that affects bone metabolism
5. Use of medications known to affect bone metabolism
6. Tobacco, cannabis or vaping use
7. Alcoholism or other recreational drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Powell, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Charles Powell, DDS, MS

Role: CONTACT

Phone: 210-567-3589

Email: [email protected]

Facility Contacts

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Charles Powell, DDS, MS

Role: primary

Other Identifiers

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STUDY00000739

Identifier Type: -

Identifier Source: org_study_id