NCT06548685

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

July 23, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

Vegetable Ivory Bone Material

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six Months

Study Arms (5)

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.

Procedure: Bone GraftingOther: 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.

Procedure: Bone GraftingOther: 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.

Procedure: Bone GraftingOther: 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.

Procedure: Bone GraftingOther: 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.

Procedure: Bone GraftingOther: Vegetable Derived

Interventions

Bone GraftingPROCEDURE

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

Participant 1Participant 2Participant 3Participant 4Participant 5

Tooth extraction followed by socket preservation with vegetable ivory

Also known as: Tooth socket preservation using Vegetable Ivory
Participant 1Participant 2Participant 3Participant 4Participant 5

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have parallel sites from which teeth have been extracted

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsOrthopedic ProceduresSurgical Procedures, OperativeTransplantation

Study Officials

  • Pasquale Scutari, D.D.S.

    St Joseph's Hospital, Syracuse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
VP

Study Record Dates

First Submitted

July 23, 2024

First Posted

August 12, 2024

Study Start

September 1, 2024

Primary Completion

August 1, 2025

Study Completion

November 1, 2025

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share