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

Trial Summary

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 data supports the effectiveness of the treatment Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral for alveolar ridge preservation?

Research shows that using demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM) can help maintain the shape and size of the jawbone after tooth extraction, which is important for future dental procedures. These materials are used to fill the space left by the extracted tooth, helping to preserve the bone structure. ^{1 2 3 4 5}

Is the combination of demineralized freeze-dried bone allograft and deproteinized bovine bone mineral safe for humans?

The studies suggest that using demineralized freeze-dried bone allograft (DFDBA) and deproteinized bovine bone mineral (DBBM) in dental procedures like alveolar ridge preservation and sinus augmentation is generally safe, as they are commonly used materials in these contexts without reported safety issues. ^{1 2 3 5 6}

How is the Mix of DFDBA and DBBM treatment different from other treatments for alveolar ridge preservation?

The Mix of DFDBA and DBBM treatment is unique because it combines two different bone graft materials to preserve the alveolar ridge after tooth extraction, potentially offering the benefits of both materials. This combination aims to limit bone loss and maintain the ridge's shape, which is important for future dental implants. ^{1 4 5 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Electronic cigarette usage

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. 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]

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

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

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

The effects of varying degrees of allograft decalcification on cultured porcine osteoclast cells. [2016]

4. 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]

5. Iran 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. [2020]

6. United States 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. [2013]

7. France 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. [2023]

8. United States 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. [2022]