What side effects are associated with this type of intervention?

Common treatments for a toothless alveolar ridge include autografts, allografts, xenografts, and alloplastic grafts. Autografts, while highly effective due to their osteogenic, osteoinductive, and osteoconductive properties, can cause significant morbidity due to the need for a second surgical site. Allografts, such as Freeze-Dried Bone Allograft (FDBA), are widely used due to lower morbidity but may carry risks of immune reactions and disease transmission. Xenografts and alloplastic grafts, while generally safe, can sometimes lead to inflammatory responses or graft rejection. Mineralized and partially demineralized dentin grafts, being studied for their potential benefits, may share similar risks, including infection, inflammation, and graft failure.

What prior FDA approvals exist?

The FDA has approved various bone grafting materials for the treatment of the toothless alveolar ridge, focusing on those with osteoinductive and osteoconductive properties. Autografts, which are harvested from the patient's own body, are considered the gold standard due to their predictable results in osteogenesis, osteoinduction, and osteoconduction. However, due to the high morbidity associated with harvesting, allografts such as Freeze-Dried Bone Allograft (FDBA) are commonly used. These allografts, derived from cadaver sources, provide osteoinductive and osteoconductive benefits with less morbidity. The ongoing studies on mineralized and partially demineralized dentin grafts aim to offer similar or improved outcomes compared to FDBA.

What other types of research exist?

Promising novel alternatives to mineralized and partially demineralized dentin grafts for toothless alveolar ridge patients include anorganic bovine bone grafts such as InterOss and Bio-Oss. These materials have shown efficacy in preclinical trials for bone regeneration. Additionally, allografts like Freeze-Dried Bone Allograft (FDBA) are considered a standard of care due to their osteoinductive and osteoconductive properties with lower morbidity compared to autografts.

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Bone Graft

Dental Implants with Bone Grafts for Toothless Patients

N/A

Waitlist Available

Led By Robin Henderson, DDS, 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

Be older than 18 years old

Must not have

Current use of bisphosphonates or history of IV bisphosphonate therapy.

Presence of active periodontal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new tooth-based bone grafts against standard human bone grafts in patients needing bone grafts for dental implants. The grafts help new bone grow to support the implants by acting like a scaffold.

Who is the study for?

This trial is for adults aged 18 to 80 with well-controlled health conditions, who need dental implants and can consent to study requirements. It's not for those with recent head/neck radiation, active gum disease, uncontrolled health issues, heavy smokers, bisphosphonate users, or pregnant/lactating women.

What is being tested?

The trial tests if mineralized or partially demineralized dentin grafts used in dental implant placement are as effective as the standard cadaver bone graft (FDBA) in terms of implant stability and success rates without requiring a second surgical site.

What are the potential side effects?

While specific side effects aren't listed for this procedure, typical risks may include infection at the surgery site, inflammation or pain around the implant area, and potential rejection of the graft material.

Eligibility Criteria

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 bisphosphonates.

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I have active gum disease.

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

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Implant Failure Rate

Implant Stability as Measured with ISQ values of implant

Interproximal crestal bone level

+1 more

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: mineralized tooth graftExperimental Treatment1 Intervention

edentulous site grafted with mineralized tooth graft in the previous study.

Group II: Partially-demineralized tooth graftExperimental Treatment1 Intervention

edentulous site grafted with partially-demineralized tooth graft in the previous study.

Group III: Freeze-Dried Bone AllograftExperimental Treatment1 Intervention

edentulous site grafted with FDBA in previous study.

0 / 4Eligibility 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

Common treatments for Toothless Alveolar Ridge include the use of bone graft materials such as autografts, allografts, xenografts, and alloplastic grafts. These treatments work primarily through osteoinduction and osteoconduction. Osteoinduction involves the stimulation of progenitor cells to develop into osteoblasts, which are essential for new bone formation. Osteoconduction provides a scaffold that supports the growth of new bone by allowing the migration of osteogenic cells. These mechanisms are crucial for patients with Toothless Alveolar Ridge as they promote the regeneration of bone, ensuring better stability and support for dental implants, ultimately improving oral function and aesthetics.

Effects of the bilayer nano-hydroxyapatite/mineralized collagen-guided bone regeneration membrane on site preservation in dogs.