Bone Allograft Fibers vs Particles for Jawbone Loss

Overseen By Angela Palaiologou-Gallis, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Pregnancy, Mental incompetence, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Baseline to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments to determine which better encourages bone growth in the jaw. It examines the use of demineralized bone allograft fibers (DFDBA fibers or Grafton DBM) or particles mixed with another material (DBBM) during a procedure to support dental implants. The goal is to identify which option results in more new bone formation and improved X-ray outcomes. Suitable participants are those needing sinus surgery to support dental implants and who smoke fewer than 10 cigarettes a day. As an unphased trial, this study provides a unique opportunity to contribute to innovative dental research and potentially benefit from advanced treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these bone allograft materials are safe for jawbone loss treatment?

Research shows that demineralized bone allograft (DFDBA) fibers and particles are generally safe and well-tolerated in people. Studies on DFDBA fibers indicate they actively promote bone growth and are safe for use in surgeries involving the spine or injuries. They help new bone grow without causing harm.

DFDBA particles have been safely used in dental procedures like sinus lifts, supporting bone growth in the jaw. Reports suggest these particles effectively create strong new bone and are safe for patients.

Both DFDBA fibers and particles originate from human donations and have a long history of use in medicine, supporting their safety record. Although these treatments are not new, ongoing research ensures they remain safe and effective for bone growth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using demineralized bone allograft (DFDBA) fibers and particles in treating jawbone loss because they offer a unique approach compared to traditional bone graft materials. Unlike conventional options that might rely solely on natural bone or synthetic substitutes, these treatments use a mix of DFDBA with deproteinized bovine bone mineral (DBBM), which could enhance bone regeneration. This combination aims to provide a scaffold that supports new bone growth more effectively. The use of fibers versus particles could also influence how well the graft integrates with existing bone, potentially leading to better outcomes for patients with jawbone loss.

What evidence suggests that this trial's treatments could be effective for jawbone loss?

This trial will compare the effectiveness of demineralized bone allograft (DFDBA) fibers and particles for jawbone growth. Research has shown that DFDBA fibers, used in one arm of this trial, succeed in dental procedures like sinus lifts and supporting implants, leading to new bone formation. Similarly, DFDBA particles, used in another arm, have proven effective in increasing bone in the upper jaw. Clinical evaluations indicate that these particles promote bone growth and are safe with the body's tissues. Both DFDBA fibers and particles show promise for enhancing jawbone growth and aiding dental procedures. ^{2 3 5 6 7}

Who Is on the Research Team?

Angela Palaiologou-Gallis, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals experiencing jawbone loss who require sinus augmentation, a type of dental surgery. Participants must be healthy enough for the procedure and not have conditions that could interfere with bone healing or the study's outcomes.

Inclusion Criteria

I need a procedure to prepare for dental implants in the upper back part of my mouth.

I am a nonsmoker, former smoker, or smoke less than 10 cigarettes a day.

I am a woman who cannot become pregnant due to surgery or menopause.

Exclusion Criteria

Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)

Pregnant women or women intending to become pregnant during study period

Patients who disclose that they will not be able to cooperate with the follow-up schedule

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo sinus augmentation with either DFDBA fibers or particles mixed with DBBM

Baseline to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including histological assessment of vital bone formation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Demineralized Bone Allograft Fibers
• Demineralized Bone Allograft Particles

Trial Overview The trial is testing two different materials used in sinus augmentation: DFDBA fibers versus DFDBA particles, both added to another material called DBBM. The goal is to see which combination leads to better bone formation after six months.

How Is the Trial Designed?

Group I: DFDBA Particles with DBBM Experimental Treatment 2 Interventions

After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.

Group II: DFDBA Fibers with DBBM Active Control 2 Interventions

After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.

Demineralized Bone Allograft Fibers is already approved in United States, European Union for the following indications:

Approved in United States as Grafton DBM for:

• Spine and trauma surgery
• Bony voids or gaps of the skeletal system
• Dental intraosseous, oral, and cranio-/maxillofacial defects
• Sinus lifts

Approved in European Union as AlloGraft Demineralized Fibers for:

• Orthopedic or reconstructive bone grafting procedures
• Maxillary sinus augmentation

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

Demineralized freeze-dried bone allograft (DFDBA) is effective in maintaining the dimensional stability of the alveolar ridge around dental implants, potentially leading to a higher percentage of new vital bone compared to mineralized alternatives.

Using DFDBA in large horizontal gap defects at molar implant sites, along with protective measures like dense polytetrafluoroethylene membranes, can help ensure successful healing and minimize leftover biomaterial around the implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Maintaining Alveolar Ridge Volume in Molar Immediate Implant Sites. Johnson, TM., Berridge, JP., Baron, D.[2020]

Demineralized, freeze-dried bone allograft (DFDBA) is advantageous for dental procedures as it eliminates the need for a second surgery to harvest bone, while providing good handling properties and promoting bone growth.

In a case study involving the treatment of an ossifying fibroma in the mandible, DFDBA successfully filled the cavity, and after six months, the graft showed positive results, allowing for the placement of an implant-supported prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placement of implants in an ossifying fibroma defect obliterated with demineralized, freeze-dried bone allograft and Plasma-rich growth factor. Pal, U., Mishra, N.[2021]

In a study involving 40 patients and 67 periodontal defect sites, the combination of enamel matrix derivative (EMD) with demineralized freeze-dried bone allograft (DFDBA) showed significant improvements in bone fill compared to EMD alone, with a mean bone fill of 3.7 mm (74.9%) versus 2.6 mm (55.3%).

While both treatment groups demonstrated significant improvements in soft tissue parameters, there were no statistical differences between them, indicating that while EMD + DFDBA enhances hard tissue outcomes, it does not negatively impact soft tissue healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of demineralized freeze-dried bone allograft and enamel matrix derivative versus enamel matrix derivative alone for the treatment of periodontal osseous defects in humans. Gurinsky, BS., Mills, MP., Mellonig, JT.[2006]

A study involving 42 patients showed that a combination allograft of 70% mineralized and 30% demineralized freeze-dried bone allograft (FDBA) resulted in significantly greater new bone formation (36.16% vital bone) compared to 100% mineralized FDBA (24.69% vital bone).

Both graft types provided similar dimensional stability of the alveolar ridge, indicating that the combination allograft is more effective for bone regeneration without compromising the structural integrity of the ridge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic healing following tooth extraction with ridge preservation using mineralized versus combined mineralized-demineralized freeze-dried bone allograft: a randomized controlled clinical trial. Borg, TD., Mealey, BL.[2022]

In a study involving 32 sinus lift procedures on 26 patients, all surgeries were successful, significantly increasing ridge heights from an average of 2.84 mm to 15.2 mm after treatment, indicating the efficacy of the graft materials used.

The combination of demineralized freeze-dried bone allograft (DFDBA) with Bio-Oss or DBX alone resulted in higher new bone formation compared to DBX combined with beta-tricalcium phosphate (beta-TCP), which produced 50% less new bone, highlighting the importance of graft material selection in sinus floor augmentations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of demineralized bone allograft in a hyaluronic acid carrier for sinus lift augmentation in humans: a computed tomography and histomorphometric study. Schwartz, Z., Goldstein, M., Raviv, E., et al.[2016]

In a study involving 69 athymic rats, the 100% DBF product Strand Family achieved a 100% fusion rate and the highest fusion maturity compared to other demineralized bone matrix products, indicating its superior performance in spinal fusion.

The study found that the presence of a carrier in DBF products negatively impacted fusion outcomes, suggesting that not all demineralized bone matrices are equally effective and that composition alone does not guarantee success in bone fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-vivo Performance of Seven Commercially Available Demineralized Bone Matrix Fiber and Putty Products in a Rat Posterolateral Fusion Model. Russell, N., Walsh, WR., Lovric, V., et al.[2020]

In a study involving 40 patients, demineralized freeze-dried bone allograft (DFDBA) showed significantly greater new bone formation (38.42% vital bone) compared to mineralized freeze-dried bone allograft (FDBA) (24.63% vital bone) after ridge preservation procedures.

DFDBA also resulted in fewer residual graft particles (8.88%) compared to FDBA (25.42%), indicating better integration and effectiveness of DFDBA in promoting healing in extraction sockets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic comparison of healing after tooth extraction with ridge preservation using mineralized versus demineralized freeze-dried bone allograft. Wood, RA., Mealey, BL.[2022]

The study demonstrated that demineralized bone matrix (DBM) is osteoinductive, meaning it can promote bone formation, but the effectiveness decreases when the amount of DBM is reduced in the formulation.

Adding hyaluronic acid (HY) to DBM formulations did not affect their osteoinductive properties, but it improved handling and reduced the presence of non-vital bone particles, highlighting the importance of maintaining adequate DBM content for optimal bone regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteoinductive ability of human allograft formulations. Boyan, BD., Ranly, DM., McMillan, J., et al.[2006]

A study analyzing demineralized freeze-dried bone allografts (DFDBAs) from three commercial sources found no detectable levels of bone morphogenetic proteins (BMP-2 and BMP-4), which are thought to aid in bone regeneration.

The absence of these BMPs in DFDBA samples raises questions about their effectiveness in periodontal therapy, suggesting that unknown substances in the DFDBA may degrade any BMPs that could be present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of bone morphogenetic proteins 2 and 4 in commercial demineralized freeze-dried bone allograft preparations: pilot study. Li, H., Pujic, Z., Xiao, Y., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17348885/

Clinical evaluation of demineralized bone allograft in a ... This clinical study was based on the hypothesis that the clinical effectiveness of demineralized freeze-dried bone allograft/demineralized bone matrix (DFDBA/ ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06173791

Study Details | Demineralized Bone Allograft Fibers Versus ... The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent ...

3. researchgate.net researchgate.net/publication/299353672_Experimental_Evaluation_of_the_Effectiveness_of_Demineralized_Bone_Matrix_and_Collagenated_Heterologous_Bone_Grafts_Used_Alone_or_in_Combination_with_Platelet-Rich_Fibrin_on_Bone_Healing_in_Sinus_Floo

Experimental Evaluation of the Effectiveness ... Purpose: The aim of this study was an experimental evaluation of the effectiveness of demineralized bone matrix (DBM) and collagenated ...

4. withpower.com withpower.com/trial/phase-bone-loss-in-jaw-8-2023-7564b

Bone Allograft Fibers vs Particles for Jawbone Loss Studies have demonstrated successful outcomes in dental procedures, such as sinus lifts and implant support, using DFDBA, indicating its potential effectiveness ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10706024/

Allogenic Bone Graft in Dentistry: A Review of Current ... In this article, we aim to review the available literature on allogenic bone and its derivatives as well as the influence of different preparation methods on ...

6. medtronic.com medtronic.com/en-us/l/isw/grafton-dbm-indications-safety-warnings.html

Grafton DBM Bone Graft - Indications, Safety, and Warnings View indications, safety, and warnings for Grafton DBM Bone Graft, a demineralized bone matrix (DBM) used in spine and trauma surgery.

7. straumann.com straumann.com/content/dam/media-center/straumann/en/documents/brochure/product-information/490.606-en_low.pdf

allografts Human allografts are biologically active, safe and readily available alternatives to autologous grafts. Their properties, compositions and.