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

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. 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 vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.

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 data supports the effectiveness of the treatment Demineralized Bone Allograft Fibers and Particles for jawbone loss?

Research shows that demineralized freeze-dried bone allograft (DFDBA) is effective in supporting bone growth and maintaining bone structure, as it is osteoinductive (encourages new bone formation). Studies have demonstrated successful outcomes in dental procedures, such as sinus lifts and implant support, using DFDBA, indicating its potential effectiveness for jawbone loss. ^{1 2 3 4 5}

Is the use of demineralized bone allograft fibers and particles generally safe in humans?

The available studies suggest that demineralized bone allografts, including fibers and particles, are generally safe for use in humans, as they have been used in various dental and orthopedic procedures without significant safety concerns reported. However, specific safety data for each product may vary, and it is important to consult with a healthcare provider for personalized advice. ^{1 2 3 6 7}

How is the treatment using demineralized bone allograft fibers and particles unique for jawbone loss?

This treatment is unique because it uses demineralized bone allograft fibers and particles, which are known for their osteoinductive properties (ability to stimulate new bone growth) due to the presence of bone morphogenetic proteins. This approach may offer advantages in bone regeneration compared to other treatments that do not utilize these specific components. ^{1 3 5 8 9}

Research Team

Angela Palaiologou-Gallis, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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 am between 18 and 89 years old.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Osteoinductive ability of human allograft formulations. [2006]

2. India 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. [2021]

3. Denmark 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. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Protocol for Maintaining Alveolar Ridge Volume in Molar Immediate Implant Sites. [2020]

5. United States 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. [2022]

6. United States 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. [2006]

7. Switzerland 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Identification of bone morphogenetic proteins 2 and 4 in commercial demineralized freeze-dried bone allograft preparations: pilot study. [2022]