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NCT Number: NCT06548685

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

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.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone grafting

Procedure

Bone grafting in some sites and Vegetable Ivory Grafting in Parallel sites

Vegetable Derived

Other

Tooth extraction followed by socket preservation with vegetable ivory

Other names: Tooth socket preservation using Vegetable Ivory

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Stanczyk

CONTACT

[email protected]

315-263-7976

Michele O'Brien, HRPP

CONTACT

[email protected]

+1 315 744 1186

Sponsors and collaborators

Lead sponsor

Mark Stanczyk

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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