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

NCT ID: NCT06548685

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-11-30

Brief Summary

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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

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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

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Bone Volume

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Bone Grafting

Intervention Type PROCEDURE

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

Vegetable Derived

Intervention Type OTHER

Tooth extraction followed by socket preservation with vegetable ivory

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.

Group Type OTHER

Bone Grafting

Intervention Type PROCEDURE

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

Vegetable Derived

Intervention Type OTHER

Tooth extraction followed by socket preservation with vegetable ivory

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.

Group Type OTHER

Bone Grafting

Intervention Type PROCEDURE

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

Vegetable Derived

Intervention Type OTHER

Tooth extraction followed by socket preservation with vegetable ivory

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.

Group Type OTHER

Bone Grafting

Intervention Type PROCEDURE

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

Vegetable Derived

Intervention Type OTHER

Tooth extraction followed by socket preservation with vegetable ivory

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.

Group Type OTHER

Bone Grafting

Intervention Type PROCEDURE

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

Vegetable Derived

Intervention Type OTHER

Tooth extraction followed by socket preservation with vegetable ivory

Interventions

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Bone Grafting

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

Intervention Type PROCEDURE

Vegetable Derived

Tooth extraction followed by socket preservation with vegetable ivory

Intervention Type OTHER

Other Intervention Names

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Tooth socket preservation using Vegetable Ivory

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mark Stanczyk

INDUSTRY

Sponsor Role lead

Responsible Party

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Mark Stanczyk

VP

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Pasquale Scutari, D.D.S.

Role: PRINCIPAL_INVESTIGATOR

St Joseph's Hospital, Syracuse

Central Contacts

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Mark Stanczyk

Role: CONTACT

315-263-7976

Michele O'Brien, HRPP

Role: CONTACT

+1 315 744 1186

Other Identifiers

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Dentivia

Identifier Type: -

Identifier Source: org_study_id

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