What side effects are associated with this type of intervention?

Common treatments for alveolar bone loss that promote osteogenesis, osteoinduction, and osteoconduction include autografts, allografts, xenografts, and alloplastic grafts. Autografts, while highly effective, can cause significant morbidity due to the need for a second surgical site for bone harvesting. Allografts, derived from cadaver sources, carry a lower risk of morbidity but may have a risk of disease transmission and immune rejection. Xenografts, sourced from animals, also pose a risk of immune rejection and disease transmission. Alloplastic grafts, made from synthetic materials, generally have fewer biological risks but may not integrate as well with the natural bone. Each treatment option has its own set of potential side effects that should be considered in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved various treatments for alveolar bone loss that focus on osteogenesis, osteoinduction, and osteoconduction. Autografts, such as autogenous bone grafts, are considered the gold standard due to their predictable results in bone regeneration. However, due to the high morbidity associated with harvesting autografts, allografts like Freeze-Dried Bone Allograft (FDBA) are commonly used. These allografts possess osteoinductive and osteoconductive properties but lack osteogenesis. There is ongoing research into autogenous dentin grafts, which have shown promising results in promoting all three mechanisms of bone regeneration, although they are not yet widely studied or approved for clinical use in humans.

What other types of research exist?

Promising alternatives to autogenous dentin grafts for alveolar bone loss include Freeze-Dried Bone Allograft (FDBA), which is currently the standard of care due to its osteoinductive and osteoconductive properties with less morbidity. Additionally, advancements in stem cell therapy and tissue engineering are emerging as novel solutions, potentially offering enhanced bone regeneration capabilities.

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Bone Graft

Dentin Graft vs Bone Allograft for Alveolar Bone Loss

N/A

Waitlist Available

Led By Robin Henderson, DMD MS

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Alveolar sockets with intact four-wall architecture

Be older than 18 years old

Must not have

Bisphosphonates current use or history of IV bisphosphonate

Presence of active periodontal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post guided bone regeneration procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using parts of a patient's own teeth for bone grafts is more effective than using other sources. The study focuses on dental patients who need new bone growth. The treatment works by stimulating and supporting new bone formation better than current methods. Recently, techniques have been reported that involve the preparation of extracted teeth from patients for bone graft purposes.

Who is the study for?

This trial is for adults over 18 with teeth needing extraction and intact alveolar sockets. Participants must understand and agree to the study's requirements. It excludes pregnant or lactating women, those with active gum disease, root-filled or infected teeth, heavy smokers, uncontrolled diseases, past head/neck radiation therapy, or bisphosphonate use.

What is being tested?

The study compares three bone graft materials in dental surgery: Mineralized Dentin Graft (MDG), Partial-Demineralized Dentin Graft (PDDG), and Freeze-Dried Bone Allograft (FDBA). The goal is to see which material best promotes bone regeneration clinically and on X-rays.

What are the potential side effects?

Potential side effects may include discomfort at the graft site, swelling, infection risk increase due to surgery, allergic reactions to graft materials if any existent allergies are unknown prior to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tooth sockets are fully intact.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using or have used IV bisphosphonates.

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I have active gum disease.

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I have a tooth infection at the root.

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I have had radiotherapy on my head or neck in the last 5 years.

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I have a disease that is not currently under control.

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I have an acute infection in a tooth that needs to be extracted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post guided bone regeneration procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post guided bone regeneration procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post guided bone regeneration procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.

Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.

Secondary study objectives

Surgical cost saving measurement utilizing dentin tooth graft and FDBA.

Surgical efficiency utilizing dentin tooth graft and FDBA.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Partial-Demineralized Dentin GraftExperimental Treatment1 Intervention

-Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines).

Group II: Mineralized Dentin GraftExperimental Treatment1 Intervention

-Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines)

Group III: Freeze-Dried Bone Allograft ControlExperimental Treatment1 Intervention

-Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mineralized Dentin Graft

2021

N/A

~50

Partial-Demineralized Dentin Graft

2021

N/A

~50

Freeze-Dried Bone Allograft control

2021

N/A

~50

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for alveolar bone loss, such as autogenous dentin grafts, work through three primary mechanisms: osteogenesis, osteoinduction, and osteoconduction. Osteogenesis involves the formation of new bone by osteoblasts present in the graft material. Osteoinduction is the process by which the graft material induces the differentiation of progenitor cells into osteoblasts, promoting new bone formation. Osteoconduction provides a scaffold that supports the growth of new bone along its surface. These mechanisms are crucial for patients with alveolar bone loss as they collectively enhance bone regeneration, improve structural integrity, and support the stability of dental implants or natural teeth.