OsteoGen Plug vs. Bone Allograft for Wisdom Tooth Extraction

Recruiting at 7 trial locations

Overseen By Todd Scheyer, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGuire Institute

Must not be taking: Corticosteroids, Immunosuppressants, Anticoagulants, others

Disqualifiers: Tobacco/Cannabis use, Uncontrolled conditions, others

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

Compensation: Varies

Number of Visits: 143

Duration: 1 day

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as those affecting gum conditions, corticosteroids, immunosuppressants, and some blood thinners, unless you have medical clearance to pause them during the procedure.

What data supports the effectiveness of the treatment Freeze-dried Bone Allograft with Collagen Barrier for wisdom tooth extraction?

Research shows that demineralized freeze-dried bone allograft (DFDBA) can help maintain bone structure after tooth extraction, which is important for healing. Studies also suggest that DFDBA can lead to new bone growth and is effective in supporting dental implants. ^{1 2 3 4 5}

Is the OsteoGen Plug or Bone Allograft safe for use in humans?

Research on freeze-dried bone allografts (FDBA and DFDBA) used in dental procedures like tooth extraction and ridge preservation suggests they are generally safe for humans, as they are commonly used by clinicians and have been studied for their healing properties. ^{1 3 4 5 6}

What makes the OsteoGen Plug treatment unique for wisdom tooth extraction?

The OsteoGen Plug treatment is unique because it combines freeze-dried bone allograft with a collagen barrier, which helps preserve the bone structure after wisdom tooth extraction. This combination can maintain the shape and stability of the bone better than some other materials, potentially leading to more new bone formation and better healing. ^{1 3 5 7 8}

Eligibility Criteria

This trial is for individuals who need their wisdom teeth removed and have a healthy outer wall of the socket. It's not suitable for those with certain health conditions or habits that could affect bone healing.

Inclusion Criteria

I am willing and able to follow the study's procedures and instructions.

The teeth next to my treatment site are natural and healthy.

I can take care of my own oral hygiene without help.

Exclusion Criteria

I am taking medication that can affect my gum health.

I have received intravenous bisphosphonates in the past.

Subjects with reported allergy or hypersensitivity to any of the products to be used in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Tooth extraction and debridement followed by packing sockets with either OsteoGen® Plug or BioGide

1 day

1 visit (in-person)

Follow-up

Participants undergo follow-up assessments for oral exams, PROs, AEs, and complication assessments

120 days

Multiple visits at days 7, 14, 30, 60, 90, and 120

Optional Follow-up

Optional follow-up assessments for oral exams, AEs, complication assessments, and additional procedures

23 days

Visits at days 135 and 143

Treatment Details

Interventions

• Freeze-dried Bone Allograft with Collagen Barrier
• OsteoGen Plug

Trial Overview The study compares two methods of preserving jawbone after wisdom tooth removal: OsteoGen Plug (a synthetic material) versus freeze-dried bone graft with a collagen barrier.

Participant Groups

Group I: OsteoGen Plug Experimental Treatment 1 Intervention

OsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket.

Group II: BioGide Active Control 1 Intervention

This product is SOC treatment and will be used per packaging instructions.

Freeze-dried Bone Allograft with Collagen Barrier is already approved in United States, European Union, China for the following indications:

Approved in United States as Freeze-dried Bone Allograft with Collagen Barrier for:

• Alveolar ridge preservation
• Bone grafting for dental procedures

Approved in European Union as Freeze-dried Bone Allograft with Collagen Barrier for:

• Alveolar ridge preservation
• Bone grafting for dental procedures

Approved in China as Freeze-dried Bone Allograft with Collagen Barrier for:

• Alveolar ridge preservation
• Bone grafting for dental procedures

Who Is Running the Clinical Trial?

McGuire Institute

Lead Sponsor

Trials

7

Recruited

390+

Impladent LTD

Collaborator

Trials

1

Recruited

70+

Findings from Research

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, both cortical and cancellous freeze-dried bone allografts (FDBA) showed no significant difference in new bone formation after tooth extraction and ridge preservation, indicating similar efficacy in promoting bone healing.

However, the cortical FDBA group retained more residual graft material, while the cancellous FDBA group had a higher percentage of non-mineralized connective tissue, suggesting different healing characteristics between the two types of grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. Eskow, AJ., Mealey, BL.[2014]

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 45 patients with maxillofacial bony defects, the use of platelet-rich plasma (PRP) enriched demineralized freeze-dried bone allograft (DFDBA) resulted in significantly greater bone density compared to DFDBA alone and a control group without grafting.

The findings suggest that PRP-enriched DFDBA not only promotes new bone formation effectively but also has osteoconductive and osteoinductive properties, making it a highly effective grafting material with minimal immunological response for reconstructive purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of plasma-enriched demineralized freeze-dried bone matrix in postsurgical jaw defects. Sethi, AK., Kar, IB., Mohanty, T., et al.[2022]

In a study involving 20 patients with cysts, the use of decalcified freeze-dried bone allograft (DFDBA) significantly increased bone density in small osseous defects compared to those who did not receive the graft, with notable differences observed at 3 and 6 months post-surgery.

The results indicate that DFDBA enhances bone regeneration, as evidenced by higher radiographic bone density measurements, suggesting it is an effective option for improving healing in minor oral surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of decalcified freeze-dried bone allograft in the regeneration of small osseous defect: A comparative study. Jaiswal, Y., Kumar, S., Mishra, V., et al.[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]

Using a palatal connective tissue membrane along with demineralized freeze-dried bone allograft (DFDBA) for socket preservation after tooth extraction resulted in significantly less decrease in socket width, keratinized tissue, and gingival level compared to using DFDBA alone, based on a study of 12 extraction sites.

While both treatment groups experienced a reduction in socket dimensions, the case group (with the membrane) showed better preservation, indicating that the connective tissue membrane may enhance the efficacy of socket preservation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and biometrical evaluation of socket preservation using demineralized freeze-dried bone allograft with and without the palatal connective tissue as a biologic membrane. Moghaddas, H., Amjadi, MR., Naghsh, N.[2022]

References

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

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

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

Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. [2014]

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. India pubmed.ncbi.nlm.nih.gov

Use of plasma-enriched demineralized freeze-dried bone matrix in postsurgical jaw defects. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Efficacy of decalcified freeze-dried bone allograft in the regeneration of small osseous defect: A comparative study. [2022]

7. 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]

8. Iran pubmed.ncbi.nlm.nih.gov

Clinical and biometrical evaluation of socket preservation using demineralized freeze-dried bone allograft with and without the palatal connective tissue as a biologic membrane. [2022]