Bone VolumeNCT06548685
Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing
A study testing Bone Grafting and Vegetable Derived in people with Bone Volume, run by Mark Stanczyk.
Trial summary
The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Volume
- What is being tested?
- Bone Grafting and Vegetable Derived
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Nov 2025
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have parallel sites from which teeth have been extracted
Who cannot join
- They are not a candidate for bone grafting or a dental implant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Vegetable Ivory Bone Material Study to Evaluate Whether a Biobased Natural Vegetable Ivory Formulation Can Produce Similar or Better Results Compared to Current Standard Bone Healing Treatments
The purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.
Read the detailed description
The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.
Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.
- Conditions
- Bone Volume
- Being tested
- Bone Grafting, Vegetable Derived
- Keywords
- Vegetable Ivory Bone Material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone GraftingProcedure or surgery
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Vegetable DerivedOther
Also called Tooth socket preservation using Vegetable Ivory
Tooth extraction followed by socket preservation with vegetable ivory
| Study group | Role | What they receive |
|---|---|---|
| Participant 1 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. Receives: Procedure: Bone Grafting; Other: Vegetable Derived |
| Participant 2 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. Receives: Procedure: Bone Grafting; Other: Vegetable Derived |
| Participant 3 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. Receives: Procedure: Bone Grafting; Other: Vegetable Derived |
| Participant 4 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. Receives: Procedure: Bone Grafting; Other: Vegetable Derived |
| Participant 5 | Other | Bone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. Receives: Procedure: Bone Grafting; Other: Vegetable Derived |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with completely healed bone graft surgical site
The number of participants who have bone volumes that match or exceed the control sites.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone VolumeStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Stanczyk
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Mark Stanczyk, Dentivia, LLC
- Investigators
- Pasquale Scutari, D.D.S., Principal investigator, St Joseph's Hospital, Syracuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548685
- Sponsor's protocol ID
- Dentivia
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vegetable Ivory Bone Material Study to Evaluate Whether a Biobased Natural Vegetable Ivory Formulation Can Produce Similar or Better Results Compared to Current Standard Bone Healing Treatments
- ClinicalTrials.gov ID
- NCT06548685
- Acronym / sponsor ID
- Dentivia
- Conditions
- Bone Volume
- Keywords
- Vegetable Ivory Bone Material
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Mark StanczykIndustry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 12 Aug 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 purpose of this research study is to evaluate whether a biobased natural vegetable ivory formulation can produce similar or better results compared to the current standard bone healing treatment.
Detailed description
The patient is identified and surgical site and sides reviewed. The patient is consented to have bilateral tooth extractions which are mirror images of each other either in the maxilla or mandible.
Local anesthesia is administered and attention directed to the bilateral identified teeth. Each tooth is luxated with a straight elevator and removed with a forcep with out bony removal. The sites are curetted as indicated, irrigated with normal saline irrigation , then the sterile bone graft material (allograft and vegetable ivory bone graft) are reconstituted with sterile normal saline and placed in the tooth sockets then sutures with a 3-0 gut suture. Once hemostasis is obtained and pot operative care instructions are given, the patient is monitored for 30 minutes following the procedure then discharged.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Participant 1 | Other | Procedure: Bone Grafting, Other: Vegetable DerivedBone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
| Participant 2 | Other | Procedure: Bone Grafting, Other: Vegetable DerivedBone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
| Participant 3 | Other | Procedure: Bone Grafting, Other: Vegetable DerivedBone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
| Participant 4 | Other | Procedure: Bone Grafting, Other: Vegetable DerivedBone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
| Participant 5 | Other | Procedure: Bone Grafting, Other: Vegetable DerivedBone grafting at one site and Vegetable Ivory Bone grafting at a parallel site in a tooth socket bone preservation intervention where the "drug' is the vegetable ivory bone replacement material in one site and human allograft bone graft on the other. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have parallel sites from which teeth have been extracted
Key exclusion criteria (1 listed)
- They are not a candidate for bone grafting or a dental implant
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 |
|---|---|---|
| Bone GraftingBone grafting in some sites and Vegetable Ivory Grafting in Parallel sites | Procedure or surgery | Participant 1, Participant 2, Participant 3, Participant 4, Participant 5 |
| Vegetable DerivedAlso: Tooth socket preservation using Vegetable IvoryTooth extraction followed by socket preservation with vegetable ivory | Other | Participant 1, Participant 2, Participant 3, Participant 4, Participant 5 |
Primary outcome
Number of participants with completely healed bone graft surgical site
Time frame: Six Months
The number of participants who have bone volumes that match or exceed the control sites.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Pasquale Scutari, D.D.S. principal investigator
St Joseph's Hospital, Syracuse
Questions about this trial
What is this clinical trial studying?
A study testing Bone Grafting and Vegetable Derived in people with Bone Volume, run by Mark Stanczyk.
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 1 inclusion and 1 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 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mark Stanczyk (315-263-7976, markstanczyk@dentivia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with completely healed bone graft surgical site (time frame: Six 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 12 Aug 2024.