New Material Mix for Alveolar Ridge Preservation

Overseen By Fatemeh Samavatijame, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Southeastern University

Must not be taking: Bisphosphonates, RANK-L inhibitors

Disqualifiers: Nicotine, E-cigarettes, Immunodeficiency, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Immediate post-extraction

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new material mix to help preserve the jawbone after tooth extraction. It will compare two treatments: one using a new combination of bone graft materials—a mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral—and another using a commonly used material. The goal is to determine which option better maintains the shape and health of the jawbone. Individuals in good health who require a premolar or molar extraction, with sufficient gum tissue and minimal bone loss, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative dental research that could enhance future treatment options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that affect bone remodeling, like bisphosphonates or RANK-L inhibitors, you may not be eligible to participate.

What prior data suggests that this new grafting material is safe for alveolar ridge preservation?

Research has shown that a mix of demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM) is promising for maintaining jawbone health after tooth extraction. These materials aid in effective bone healing.

This combination strongly encourages bone growth and helps the bone retain its shape. Although specific safety data from these studies is lacking, these materials are trusted in similar procedures, suggesting they should be safe and well-tolerated.

While direct information about side effects is unavailable, existing evidence from similar uses supports the safety of this treatment mix. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new material mix for alveolar ridge preservation because it combines two different types of bone grafts: Demineralized Freeze-Dried Bone Allograft (DFDBA) and Deproteinized Bovine Bone Mineral (DBBM). This combination is paired with a collagen matrix seal, which could enhance the healing process and bone regeneration compared to traditional options like mineralized particulate allografts alone. The unique blend aims to provide a more effective framework for new bone growth by leveraging the osteoconductive properties of bovine bone mineral and the osteoinductive potential of DFDBA, potentially leading to better outcomes for patients needing alveolar ridge preservation.

What evidence suggests that this new material mix is effective for alveolar ridge preservation?

This trial will compare two different grafting materials for alveolar ridge preservation. Research has shown that a mix of DFDBA and DBBM, which participants in the test group will receive, is promising for maintaining the bone that supports teeth. Studies have found that both materials effectively maintain bone after tooth removal, and using them together might enhance bone formation. In a study with 42 patients, a similar mix significantly preserved bone. This suggests the new material could effectively maintain bone structure after tooth removal. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

No more than 3mm of buccal bone loss

Full mouth plaque index of less than 25%

I am in good health overall.

Exclusion Criteria

Nicotine consumption equivalent to or more than 10 cigarettes per day

I have a condition that weakens my immune system.

I have had radiation therapy to my head or neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo alveolar ridge preservation with either DFDBA + DBBM or Tutoplast® processed mineralized particulate allograft

Immediate post-extraction

1 visit (in-person)

Follow-up

Participants are monitored for changes in alveolar ridge dimensions and histological composition

4 months

2 visits (in-person)

Assessment

Evaluation of dimensional changes and vital bone percentage at the time of implant placement

1 visit

What Are the Treatments Tested in This Trial?

Interventions

• Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral

Trial Overview 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.

How Is the Trial Designed?

Group I: Test Group Experimental Treatment 1 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 Group Active Control 1 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.

Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral is already approved in United States, European Union for the following indications:

Approved in United States as Mix of DFDBA and DBBM for:

• Alveolar ridge preservation
• Bone grafting for dental implant placement

Approved in European Union as Mix of DFDBA and DBBM for:

• Alveolar ridge preservation
• Bone grafting for dental implant placement

Who Is Running the Clinical Trial?

Nova Southeastern University

Lead Sponsor

Trials

103

Recruited

12,000+

Geistlich Pharma AG

Industry Sponsor

Trials

45

Recruited

2,300+

ZimVie

Industry Sponsor

Trials

27

Recruited

2,400+

Published Research Related to This Trial

Both deproteinized bovine bone mineral (DBBM) and demineralized freeze-dried bone allograft (DFDBA) are effective for preserving the alveolar ridge after tooth extraction, with no significant differences in horizontal or vertical ridge dimensional changes between the two materials.

However, DFDBA resulted in significantly more new bone formation and fewer residual graft particles compared to DBBM, suggesting it may be a more effective option for socket preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled evaluation of alveolar ridge preservation following tooth extraction using deproteinized bovine bone mineral and demineralized freeze-dried bone allograft. Sadeghi, R., Babaei, M., Miremadi, SA., et al.[2020]

Using deproteinized bovine bone mineral (DBBM) as a filler material in tooth extraction sockets effectively preserves the alveolar ridge, allowing for better implant placement later on, as shown in a 9-month healing period with new bone formation in all samples.

Histological analysis revealed that DBBM particles supported the growth of new bone, indicating its biocompatibility and potential as a reliable option for ridge preservation, although further randomized controlled trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of deproteinized bovine bone mineral for ridge preservation prior to implantation. Clinical and histological observations in a case report. Artzi, Z., Nemcovsky, CE.[2022]

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]

In an in vitro study using porcine osteoclasts, DFDBA with 2.41% residual calcium significantly increased resorptive activity compared to other calcium levels, suggesting it may be optimal for bone regeneration.

The study highlights the importance of residual calcium levels in DFDBA, as varying degrees of demineralization can affect the osteoclast activity and, consequently, the effectiveness of DFDBA in periodontal therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of varying degrees of allograft decalcification on cultured porcine osteoclast cells. Herold, RW., Pashley, DH., Cuenin, MF., et al.[2016]

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, 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]

In a study involving five patients undergoing maxillary sinus floor augmentation, both deproteinized bovine bone mineral (DBBM) and human freeze-dried bone allograft (FDBA) showed similar effectiveness in promoting new bone formation after 9 months, with mean values of 31.8% for FDBA and 27.2% for DBBM.

The study found no significant differences in the amount of residual graft particles or connective tissue between the two materials, suggesting that both DBBM and FDBA are equally suitable options for sinus augmentation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histomorphometric analysis of newly formed bone after bilateral maxillary sinus augmentation using two different osteoconductive materials and internal collagen membrane. Kolerman, R., Samorodnitzky-Naveh, GR., Barnea, E., et al.[2013]

In a study involving 7 patients with 14 hopeless teeth, the combination of demineralized bovine bone material (DBBM) and cross-linked hyaluronic acid (xHyA) significantly reduced bone resorption compared to DBBM alone, with a mean volumetric resorption of 26.96% versus 36.56% in the control group.

Both treatment groups healed well, and while the xHyA group showed less bone loss, there was no significant difference in the need for additional bone grafting at the time of implant placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic assessment of cross-linked hyaluronic acid addition in demineralized bovine bone based alveolar ridge preservation: A human randomized split-mouth pilot study. Husseini, B., Friedmann, A., Wak, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06275789?locStr=United+States&country=United+States&aggFilters=funderType%3Aindustry%2Chealthy%3Ay%2Cstatus%3Anot+rec+enr+unk&firstPost=2024-01-01_

Mix of Demineralized Freeze-Dried Bone Allograft and ... Specific Aims: The primary goal of the study is to compare the dimensional changes following alveolar ridge preservation with a new material that combines DFDBA ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27076830/

A randomized controlled evaluation of alveolar ridge ... Based on the findings of this study, both materials have positive effect on alveolar ridge preservation after tooth extraction, but there was more new bone ...

3. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/10.1002/jper.11374

Healing following ridge preservation using demineralized ... This study evaluated histologic wound healing when using demineralized freeze-dried bone allograft (DFDBA) alone, in fiber or particulate form, ...

4. withpower.com withpower.com/trial/phase-4-alveolar-ridge-preservation-2024-fb4d4

New Material Mix for Alveolar Ridge Preservation A study involving 42 patients showed that a combination allograft of 70% mineralized and 30% demineralized freeze-dried bone allograft (FDBA) resulted in ...

5. researchgate.net researchgate.net/publication/297663535_A_randomized_controlled_evaluation_of_alveolar_ridge_preservation_following_tooth_extraction_using_deproteinized_bovine_bone_mineral_and_demineralized_freeze-dried_bone_allograft

(PDF) A randomized controlled evaluation of alveolar ridge ... The aim of this study was to compare the clinical and histologic outcomes of socket preservation using two different graft materials; deproteinized bovine bone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11021384/

Advancements in alveolar bone grafting and ridge ... This narrative review systematically explores the progression of materials and techniques in alveolar ridge preservation (ARP).

7. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/pdf/10.1002/jper.11374

Healing following ridge preservation using demineralized ... 17 It is hypoth- esized that mixing DFDBA with DBBM may result in a highly osteoinductive graft material with enough dimen- sional stability to ...