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

Mark Stanczyk

Status: Not yet enrolling

Conditions: Bone Volume

Treatments: Procedure: Bone Grafting; Other: Vegetable Derived

Study type: Interventional

Funder types: Industry

Identifiers

NCT06548685

Dentivia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 5 patient groups

Participant 1

Other group

Description:

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.

Treatment:

Other: Vegetable Derived

Procedure: Bone Grafting

Participant 2

Other group

Description:

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.

Treatment:

Other: Vegetable Derived

Procedure: Bone Grafting

Participant 3

Other group

Description:

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.

Treatment:

Other: Vegetable Derived

Procedure: Bone Grafting

Participant 4

Other group

Description:

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.

Treatment:

Other: Vegetable Derived

Procedure: Bone Grafting

Participant 5

Other group

Description:

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.

Treatment:

Other: Vegetable Derived

Procedure: Bone Grafting