Dental ImplantsNCT06187805
Retrospective Case Series - OSSIX Volumax Collagen Xenograft Scaffolding
An observational study of Dental Implants, run by Old Orchard Periodontics and Implant Dentistry LTD at 1 site in United States.
Trial summary
This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- OSSIX Volumax
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 2 Feb 2024
- Phase
- Observational
- 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
Study population: Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.
Who may be able to join
- Transcrestal sinus lift planned
- Implant therapy planned
- Crestal bone height < or equal to 6mm
- Missing tooth or teeth for function
- Nonsmoker -
Who cannot join
- Patients with known collagen hypersensitivity
- Patients with sensitivity to porcine-derived materials
- Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
- Pregnant or planning to become pregnant (verbal confirmation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Old Orchard Periodontics and Implant Dentistry
Skokie, Illinois, 60077
About this study
Official title: Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding
This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.
Read the detailed description
The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.
- Conditions
- Dental Implants
- Being tested
- OSSIX Volumax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSSIX VolumaxDevice
OSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| Up to 15 patients | Patients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Receives: Device: OSSIX Volumax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in crestal bone height
Measured radiographically and by cone beam computed tomography at follow up
Measured: 4 months to 57 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start16 Nov 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion2 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Old Orchard Periodontics and Implant Dentistry LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187805
- Sponsor's protocol ID
- Ver 01
- Status last verified
- Jan 2024
- First submitted
- 17 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Case Series Evaluating the Outcome of Transcrestal Sinus Elevation Using Autogenous Bone Supporting an OSSIX Volumax Collagen Xenograft Scaffolding
- ClinicalTrials.gov ID
- NCT06187805
- Acronym / sponsor ID
- Ver 01
- Conditions
- Dental Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Old Orchard Periodontics and Implant Dentistry LTDUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 2 Feb 2024 (estimated)
- First posted
- 3 Jan 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.
This study is designed as a retrospective, single center study. Up to 15 participants who had a transcrestal sinus elevation and implant placement using autogenous bone supporting an OSSIX Volumax collagen xenograft scaffolding will be enrolled. The study will include data collection from medical records and data collected at a follow up visit between January 2019 and March 2023.
Detailed description
The purpose of this study is to evaluate the outcome of transcrestal sinus elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. Data to be collected includes demographics, past medical history including autoimmune diseases and connective tissue diseases, smoking history and known allergies. Implant data will be collected and change in crestal bone height will be measured radiographically and cone beam computed tomography at follow up. The protocol will include both single-staged and two-staged procedures. Adverse events will be collected and reported.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Up to 15 patients | – | Device: OSSIX VolumaxPatients who have had a transcrestal elevation using autogenous bone supporting an OSSIX Volumax collagen scaffolding. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 15 participants who meet the I/E will have data retrospectively reviewed and will include follow up data.
Key inclusion criteria (5 listed)
- Transcrestal sinus lift planned
- Implant therapy planned
- Crestal bone height < or equal to 6mm
- Missing tooth or teeth for function
- Nonsmoker -
Key exclusion criteria (4 listed)
- Patients with known collagen hypersensitivity
- Patients with sensitivity to porcine-derived materials
- Patients suffering from autoimmune diseases and connective tissue diseases, such as lupus erythematosus, dermatomyositis, etc.
- Pregnant or planning to become pregnant (verbal confirmation)
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 |
|---|---|---|
| OSSIX VolumaxOSSIX Volumax is used in combination with autogenous bone collected during preparation of the implant osteotomy. | Device | Up to 15 patients |
Primary outcome
Change in crestal bone height
Time frame: 4 months to 57 months
Measured radiographically and by cone beam computed tomography at follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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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?
An observational study of Dental Implants, run by Old Orchard Periodontics and Implant Dentistry LTD 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 4 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
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?
Change in crestal bone height (time frame: 4 months to 57 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 5 Jan 2024.