Dental ImplantNCT06296459
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
A study testing 3D R100 scanner and Conventional Radiograph in people with Dental Implant, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A closed sinus augmentation is performed for dental implant placement. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant
- What is being tested?
- 3D R100 scanner and Conventional Radiograph
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
A closed sinus augmentation is performed for dental implant placement.
Read the detailed description
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.
- Conditions
- Dental Implant
- Being tested
- 3D R100 scanner, Conventional Radiograph
- Keywords
- Cone beam computed tomography, Sinus anatomy, Dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D R100 scannerOther
Also called Veraviewpocs
A cone beam computed tomography used for planning of implant surgery
Conventional RadiographOther
Also called Standard Periapical Radiograph
Imaging used as standard of care to plan for implant surgery
| Study group | Role | What they receive |
|---|---|---|
| Low volume CBCT | Active comparator | Radiographic low volume cone beam computed tomography used to plan implant placement Receives: Other: 3D R100 scanner |
| Standard periapical radiographs | Placebo comparator | Standard radiography used to plan implant placement Receives: Other: Conventional Radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline immediately postoperatively and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start21 Sep 2022
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A 2 arm study using two methods of imaging in a participant
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
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
- NCT06296459
- Sponsor's protocol ID
- 20220556HU
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified participant data will be shared with colleagues
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. 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
- ClinicalTrials.gov ID
- NCT06296459
- Acronym / sponsor ID
- 20220556HU
- Conditions
- Dental Implant
- Keywords
- Cone beam computed tomography, Sinus anatomy, Dental implant placement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 6 Mar 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.
A closed sinus augmentation is performed for dental implant placement.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2 arm study using two methods of imaging in a participant
| Arm | Type | Receives |
|---|---|---|
| Low volume CBCT | Active comparator | Other: 3D R100 scannerRadiographic low volume cone beam computed tomography used to plan implant placement |
| Standard periapical radiographs | Placebo comparator | Other: Conventional RadiographStandard radiography used to plan implant placement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- Maxillary sinus disease.
- Pregnancy or attempting to become pregnant.
- Diseases that affect bone metabolism.
- Use of medications known to affect bone metabolism.
- Tobacco use.
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 |
|---|---|---|
| 3D R100 scannerAlso: VeraviewpocsA cone beam computed tomography used for planning of implant surgery | Other | Low volume CBCT |
| Conventional RadiographAlso: Standard Periapical RadiographImaging used as standard of care to plan for implant surgery | Other | Standard periapical radiographs |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: Yes. All deidentified participant data will be shared with colleagues
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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. This study is not recruiting at the moment.
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 3D R100 scanner and Conventional Radiograph in people with Dental Implant, 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 4 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: finished, as of the sponsor's last update on 4 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dimensional Change in augmentation at 8mm (time frame: Baseline immediately postoperatively and at 6 months). The study lists 3 primary outcomes in all. 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 4 Feb 2025.