Lateral Window Sinus AugmentationNCT03639077
Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial
A study testing Allograft bone alone and Allograft and xenograft mixture in people with Lateral Window Sinus Augmentation, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lateral Window Sinus Augmentation
- What is being tested?
- Allograft bone alone and Allograft and xenograft mixture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 9 Sep 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years old
- In need of sinus augmentation utilizing lateral window sinus technique
- Presence of bone height of < 8 mm
- Patient has good oral hygiene (<40% plaque score)
- Periodontally stable
- Willingness to fulfill all study requirements
Who cannot join
- Currently smoking > 10 cigarettes / day
- Pregnant, expecting to become pregnant or lactating mothers
- Uncontrolled Diabetes Mellitus (HbA1c >7)
- Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
- Current use of oral bisphosphonates
- History of IV bisphosphonates use
Show all 9Show fewer
- Poor oral hygiene (plaque score >40% based on O'Leary plaque score)
- Unmanageable Sinus perforations
- Significant pathology in the region of interest that may compromise the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Graduate Periodotics
Oklahoma City, Oklahoma, 73117
About this study
The purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.
Read the detailed description
This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation.
Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.
- Conditions
- Lateral Window Sinus Augmentation
- Being tested
- Allograft bone alone, Allograft and xenograft mixture
- Keywords
- Bone graft, Lateral window approach, Sinus augmentation, Volumetric change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft bone aloneDevice
The subject will receive an allograft as graft material of choice for sinus augmentation
Allograft and xenograft mixtureDevice
The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation
| Study group | Role | What they receive |
|---|---|---|
| Allograft bone alone | Experimental | Not described Receives: Device: Allograft bone alone |
| Allograft and xenograft mixture | Experimental | Not described Receives: Device: Allograft and xenograft mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft volumetric stability change
CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure
Measured: CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material
Secondary outcomes (1)
Histomorphometric analysis
Identify histological differences between two groups of graft material in sinus augmentation procedure
Measured: After 6 months of sinus augmentation procedure when the implant is placed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Oct 2018
- Primary completion24 Apr 2019
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Window Sinus AugmentationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639077
- Sponsor's protocol ID
- 9302
- Status last verified
- Mar 2024
- First submitted
- 10 Aug 2018
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It is not decided yet if there will be a possibility to publish the study in a journal.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Changes and Graft Stability in Lateral Window Sinus Augmentation: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03639077
- Acronym / sponsor ID
- 9302
- Conditions
- Lateral Window Sinus Augmentation
- Keywords
- Bone graft, Lateral window approach, Sinus augmentation, Volumetric change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 20 Aug 2018 (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 purpose of this study is to evaluate the stability and volumetric changes of the grafting materials used for lateral window sinus augmentation. In addition, different variables known to affect bone stability and remodeling with regard to the augmentation procedure will be evaluated. Similarly, implant placement will be performed and results will be evaluated after a period of six months.
Detailed description
This will be a prospective clinical study evaluating the stability and volumetric change of two grafting materials used in lateral window sinus augmentation procedure (anorganic bovine bone xenograft alone compared to a mixture of allograft and anorganic bovine bone xenograft). Participants will have the same surgical treatment of the lateral window sinus augmentation procedure. Participants will have a simultaneous implant placement at the time of sinus augmentation procedure or a delayed implant placement based on the stability of the implant evaluation.
Cone beam computed tomography (CBCT) will be used to evaluate the volumetric changes between two groups of graft material in sinus augmentation procedure at three time points: pre-operatively, two weeks post-operation and six months post-operation. Biopsies will be harvested after six months for histological and histomorphometric analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft bone alone | Experimental | Device: Allograft bone alone |
| Allograft and xenograft mixture | Experimental | Device: Allograft and xenograft mixture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 years old
- In need of sinus augmentation utilizing lateral window sinus technique
- Presence of bone height of < 8 mm
- Patient has good oral hygiene (<40% plaque score)
- Periodontally stable
Key exclusion criteria (9 listed)
- Currently smoking > 10 cigarettes / day
- Pregnant, expecting to become pregnant or lactating mothers
- Uncontrolled Diabetes Mellitus (HbA1c >7)
- Medical condition that may influence the outcome (Neurologic or psychiatric disorders, systemic infections)
- Current use of oral bisphosphonates
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 |
|---|---|---|
| Allograft bone aloneThe subject will receive an allograft as graft material of choice for sinus augmentation | Device | Allograft bone alone |
| Allograft and xenograft mixtureThe subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation | Device | Allograft and xenograft mixture |
Primary outcome
Graft volumetric stability change
Time frame: CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material
CBCT will be the primary tool to evaluate the volumetric stability of the graft material used in the sinus augmentation procedure
1 secondary outcome
Histomorphometric analysis
Time frame: After 6 months of sinus augmentation procedure when the implant is placed
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 19 Mar 2024.
- Individual participant dataSharing planned: Undecided. It is not decided yet if there will be a possibility to publish the study in a journal.
Related trials for Lateral Window Sinus Augmentation
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Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
Bone Grafting, Sinus Lifting
Recruiting
Clinical Application Strategies of Maxillary Sinus Buccal Bony Window
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allograft bone alone and Allograft and xenograft mixture in people with Lateral Window Sinus Augmentation, run by University of Oklahoma 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 6 inclusion and 9 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 19 Mar 2024. 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?
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?
Graft volumetric stability change (time frame: CBCT taken at 2 weeks after the procedure and 6 months after the procedure of sinus augmentation to assess the volumetric changes of the graft material). 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 19 Mar 2024.