Vegetable Ivory Bone Material in Bone Healing Compared to Current Standard Methods of Bone Healing

August 7, 2024 updated by: Mark Stanczyk

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Have parallel sites from which teeth have been extracted

Exclusion Criteria:

They are not a candidate for bone grafting or a dental implant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participant 1
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.
Procedure: Bone Grafting
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Other: Vegetable Derived
Tooth extraction followed by socket preservation with vegetable ivory
Other Names:
  • Tooth socket preservation using Vegetable Ivory
Other: Participant 2
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.
Procedure: Bone Grafting
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Other: Vegetable Derived
Tooth extraction followed by socket preservation with vegetable ivory
Other Names:
  • Tooth socket preservation using Vegetable Ivory
Other: Participant 3
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.
Procedure: Bone Grafting
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Other: Vegetable Derived
Tooth extraction followed by socket preservation with vegetable ivory
Other Names:
  • Tooth socket preservation using Vegetable Ivory
Other: Participant 4
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.
Procedure: Bone Grafting
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Other: Vegetable Derived
Tooth extraction followed by socket preservation with vegetable ivory
Other Names:
  • Tooth socket preservation using Vegetable Ivory
Other: Participant 5
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.
Procedure: Bone Grafting
Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites
Other: Vegetable Derived
Tooth extraction followed by socket preservation with vegetable ivory
Other Names:
  • Tooth socket preservation using Vegetable Ivory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Stanczyk

Investigators

  • Principal Investigator: Pasquale Scutari, D.D.S., St Joseph's Hospital, Syracuse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 23, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dentivia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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