Dental ImplantNCT06507709
Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
A study testing Low volume CBCT in people with Dental Implant and Maxillary Sinus Floor Augmentation, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dental Implant, Maxillary Sinus Floor Augmentation
- What is being tested?
- Low volume CBCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Calcium Phosphosilicate
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.
Read the detailed description
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.
- Conditions
- Dental Implant, Maxillary Sinus Floor Augmentation
- Being tested
- Low volume CBCT
- Keywords
- Cone beam computed tomography, Calcium Phosphosilicate putty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low volume CBCTProcedure or surgery
Also called Cone Beam Computed Tomography
3-D imaging used during dental practice
| Study group | Role | What they receive |
|---|---|---|
| Closed sinus augmentation with Calcium Phosphosilicate Putty | Experimental | 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. Receives: Procedure: Low volume CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Volume change
Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start8 Oct 2024
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series single group with no control
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Powell, DDS, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507709
- Sponsor's protocol ID
- STUDY00000739
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be thoroughly de-identified and will not be traceable to a specific study participant. Data will be shared through publication in a peer review journal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Calcium Phosphosilicate
- ClinicalTrials.gov ID
- NCT06507709
- Acronym / sponsor ID
- STUDY00000739
- Conditions
- Dental Implant, Maxillary Sinus Floor Augmentation
- Keywords
- Cone beam computed tomography, Calcium Phosphosilicate putty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series single group with no control
| Arm | Type | Receives |
|---|---|---|
| Closed sinus augmentation with Calcium Phosphosilicate Putty | Experimental | Procedure: Low volume CBCTUse 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low volume CBCTAlso: Cone Beam Computed Tomography3-D imaging used during dental practice | Procedure or surgery | Closed sinus augmentation with Calcium Phosphosilicate Putty |
Primary outcome
Bone Volume change
Time frame: Baseline to 6 months
Bone volume changes will be reported as a percentage, with mean, median, and standard deviation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. All data will be thoroughly de-identified and will not be traceable to a specific study participant. Data will be shared through publication in a peer review journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Powell, DDS, MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low volume CBCT in people with Dental Implant and Maxillary Sinus Floor Augmentation, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Volume change (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.