What side effects are associated with this type of intervention?

Common treatments for bone grafting, such as the use of demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM), are generally well-tolerated but can have some side effects. These may include local inflammation, infection at the graft site, and graft rejection. Patients might also experience pain, swelling, and bruising in the area where the graft is placed. In rare cases, there can be complications such as nerve damage or issues with graft integration, leading to graft failure.

What prior FDA approvals exist?

The FDA has approved several treatments for bone grafting, particularly those involving demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM). These materials are commonly used for bone tissue preservation and regeneration, including alveolar ridge preservation. DFDBA is derived from human bone and has been processed to remove minerals while preserving the organic matrix, which aids in bone regeneration. DBBM, on the other hand, is derived from bovine bone and is used to provide a scaffold for new bone growth. Both materials have been widely studied and utilized in clinical settings for their efficacy in promoting bone healing and regeneration.

What other types of research exist?

Promising novel alternatives to traditional grafting materials for bone tissue preservation and regeneration include: 1) Demineralized Freeze-Dried Bone Allograft (DFDBA) mixed with Deproteinized Bovine Bone Mineral, which has shown potential for alveolar ridge preservation. 2) Autologous Platelet Concentrates (APC), also known as Platelet-Rich Plasma (PRP), which have been used as adjuncts in oral surgery to enhance healing and regeneration. 3) Recombinant human bone morphogenetic protein-2 (rhBMP-2), which has been used in spinal fusion and may have applications in bone grafting due to its osteoinductive properties.

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Bone Graft

New Material Mix for Alveolar Ridge Preservation

N/A

Recruiting

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

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

Must have

Flapless extraction possible

The tooth to be extracted must be bordered by two teeth

Must not have

Immunodeficiency disease

A history of irradiation of head and neck area

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new grafting material made from processed human and cow bones to help preserve the jawbone after tooth removal. It targets patients who need a premolar extraction and plan to get a dental implant. The cow bone part helps maintain the jaw's shape, while the human bone part encourages new bone growth. The use of bovine bone matrix in bone grafting has shown good results in bone and volume preservation after tooth extraction.

Who is the study for?

This trial is for individuals needing alveolar ridge preservation after tooth extraction. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

What is being tested?

The study aims to compare a new bone grafting material with a well-established one in terms of effectiveness in preserving the alveolar ridge dimensions and tissue health following tooth extractions.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort, swelling, infection at the graft site, or rejection of the graft material.

Eligibility Criteria

Inclusion Criteria

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

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My tooth can be removed without cutting the gums.

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The tooth I need removed is between two other teeth.

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I have enough gum tissue (2mm or more) before tooth removal.

Exclusion Criteria

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

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I have a condition that weakens my immune system.

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I have had radiation therapy to my head or neck.

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I do not have uncontrolled health issues like severe high blood pressure, overactive thyroid, poorly controlled diabetes, recent stroke, or cancer.

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I have ongoing gum disease that hasn't been treated.

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I have gum or tooth infections larger than 1 cm.

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I have taken medications that affect bone health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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

changes in horizontal dimensions of the alveolar ridge

changes in vertical dimensions of the alveolar ridge

Secondary study objectives

vital bone percentage

Other study objectives

# of cigarettes and its influence on the ridge dimension

oral hygiene using the plaque index and its influence on the ridge dimension

the position of extraction site (maxilla vs. mandible) and its influence on the ridge dimension

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test GroupExperimental Treatment1 Intervention

This group will receive the grafting material that is a combination of DFDBA + DBBM + collagen matrix seal during the alveolar ridge preservation procedure.

Group II: Control GroupActive Control1 Intervention

This group will receive the grafting material that is a Tutoplast® processed mineralized particulate allograft + collagen matrix seal during the alveolar ridge preservation procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alveolar ridge preservation

2019

N/A

~120

0 / 9Eligibility 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

Bone grafting treatments commonly involve autografts, allografts, and synthetic materials. Autografts use the patient's own bone, promoting healing through osteogenesis, osteoinduction, and osteoconduction. Allografts, derived from donor bone, primarily provide a scaffold for new bone growth (osteoconduction) and can also support osteoinduction. Synthetic materials, such as demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral, offer structural support and can be combined with biological agents to enhance bone regeneration. These mechanisms are crucial for bone grafting patients as they ensure the graft integrates well with the existing bone, promoting effective healing and restoration of bone function.