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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:
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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 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

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.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
468 Previous Clinical Trials
92,468 Total Patients Enrolled
Delta Dental FoundationOTHER
7 Previous Clinical Trials
1,390 Total Patients Enrolled
1 Trials studying Alveolar Bone Loss
20 Patients Enrolled for Alveolar Bone Loss
Robin Henderson, DMD MSPrincipal InvestigatorUniversity of Oklahoma College of Dentistry

Media Library

Freeze-Dried Bone Allograft control (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT05311735 — N/A
~11 spots leftby Oct 2025
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