Bone Grafts for Tooth Extractions

(FDBA or CEBX Trial)

Overseen By Nasser Assery, BDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Immunosuppressants, Steroids, Bisphosphonates, others

Disqualifiers: Smoking, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different bone graft materials to determine which better preserves bone after a front tooth extraction and before a dental implant. One group will receive freeze-dried bone material (FDBA), while the other will receive collagen-enriched cow bone material (CEBX). The researchers aim to identify differences in bone healing and patient satisfaction. Individuals needing a front tooth extraction and planning for a dental implant may qualify if they have specific bone issues, such as a small gap in the bone. As an unphased trial, this study provides an opportunity to explore innovative materials for dental health.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications like immunosuppressants, steroids, bisphosphonates, or others related to jaw bone issues. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, patients who received freeze-dried bone allograft (FDBA) experienced good wound healing over 12 weeks, indicating that the graft material was well-accepted by the body, with no major safety issues reported. Another study found that FDBA led to significant new bone growth, a positive sign for its safety and effectiveness.

For collagen-enriched bovine xenograft (CEBX), research has shown it aids in bone healing after tooth removal, suggesting it is also well-accepted by the body. However, some reports have mentioned possible long-term risks, though these are uncommon.

Both FDBA and CEBX are regularly used in dental procedures, supporting their general safety. No major side effects or complications have been frequently reported with either treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments CEBX and FDBA for bone grafts following tooth extractions because they offer unique benefits compared to traditional options like autografts and allografts. CEBX is distinctive because it acts as an active comparator, potentially providing a more predictable integration with the existing bone. On the other hand, FDBA, a freeze-dried bone allograft, is being explored for its ease of use and reduced risk of disease transmission. These innovations could lead to improved healing times and outcomes for patients needing bone grafts after tooth removal.

What evidence suggests that this trial's treatments could be effective for preserving bone after tooth extraction?

Research has shown that freeze-dried bone allograft (FDBA), one of the treatments in this trial, effectively maintains bone after tooth removal. Studies indicate that after 15 months, the bone's width and height remain about 91% of their original size, suggesting FDBA effectively preserves bone structure. Additionally, around 18-20 weeks after using FDBA, about 36% of the new bone is healthy and living.

Collagen-enriched bovine xenograft (CEBX) is another treatment option in this trial for preserving bone. While specific numbers aren't provided here, it is known for naturally supporting bone healing. Both treatments in this trial aim to keep the bone stable and ready for future dental implants. ^{6 7 8 9 10}

Who Is on the Research Team?

Elli Anna Kotsailidi, DDS, MS

Principal Investigator

Eastman Institute for Oral Health, University of Rochester

Are You a Good Fit for This Trial?

This trial is for individuals needing a front tooth extracted and replaced with an implant. They should be suitable for bone grafting procedures using either human (FDBA) or cow-derived (CEBX) materials. Specific eligibility criteria are not provided, but typically participants must be in good general health and have adequate bone structure to support the dental work.

Inclusion Criteria

My dental scan shows my front tooth's bone is intact or slightly damaged.

Patients able to provide informed consent

I need at least one front tooth pulled out and plan to get a dental implant.

Exclusion Criteria

Uncontrolled diabetes (HbA1c≥7 in the last 3 months)

I need a tooth pulled next to a gap in my front teeth.

Current smokers or tobacco-product users (self-reported)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo tooth extraction and alveolar ridge preservation with either FDBA or CEBX, followed by healing

16 weeks

Multiple visits aligned with standard of care procedures

Implant Placement and Crown Restoration

Implant placement and crown restoration are performed after healing

Approximately 2 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and esthetic outcomes after implant placement

12 months

Regular follow-up visits at 2 and 12 months post-implant

What Are the Treatments Tested in This Trial?

Interventions

• CEBX
• FDBA

Trial Overview The study compares two types of bone grafts: FDBA from humans and CEBX from cows, used after removing a front tooth. It aims to see which material better preserves jawbone shape over 16 weeks before placing an implant. Participants will randomly receive one type of graft during standard care visits.

How Is the Trial Designed?

Group I: FDBA arm Experimental Treatment 1 Intervention

Group II: CEBX arm Active Control 1 Intervention

CEBX is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Bio-Oss Collagen for:

• Dental implantology
• Bone augmentation
• Sinus floor elevation
• Ridge preservation

Approved in United States as Bio-Oss Collagen for:

• Dental implantology
• Bone augmentation
• Sinus floor elevation
• Ridge preservation

Approved in Canada as Bio-Oss Collagen for:

• Dental implantology
• Bone augmentation
• Sinus floor elevation
• Ridge preservation

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Implant Dentistry Research & Education Foundation (IDREF)

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study involving 36 mice, Bio-Oss showed significantly greater bone volume compared to demineralized freeze-dried bone allograft (DFDBA) and control groups at both 1 and 3 months after grafting, indicating its superior efficacy in promoting bone regeneration.

Both Bio-Oss and DFDBA increased the expression of key bone marker genes over time, with Bio-Oss exhibiting particularly strong osteoconductive properties, suggesting it may be more effective for bone healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gene Expression and Microcomputed Tomography Analysis of Grafted Bone Using Deproteinized Bovine Bone and Freeze-Dried Human Bone. Kangwannarongkul, T., Subbalekha, K., Vivatbutsiri, P., et al.[2019]

In a study involving 6 patients and 7 extraction sites, demineralized freeze-dried bone allografts (DFDBA) were found to be well incorporated into new bone up to 13 months after treatment, indicating their potential for promoting bone growth.

Histological analysis showed that DFDBA particles remained identifiable and were surrounded by new bone without significant inflammation or fibrous encapsulation, suggesting a favorable environment for bone regeneration in extraction sockets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic evaluation of human extraction sockets treated with demineralized freeze-dried bone allograft (DFDBA) and cell occlusive membrane. Brugnami, F., Then, PR., Moroi, H., et al.[2008]

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 allografts (DFDBA) like Osseo+, AlloOss, and Cenobone show osteoinductive activity in vitro, promoting osteogenic differentiation in human osteoblast-like cells (SaOS-2) when tested at a concentration of 16 mg/mL.

While lower concentrations (8 mg/mL) of Osseo+ and Cenobone increased cell proliferation, higher concentrations (16 mg/mL) led to decreased proliferation but enhanced mineralization and osteogenic gene expression, indicating a complex relationship between concentration and cellular response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro assay for osteoinductive activity of different demineralized freeze-dried bone allograft. Vaziri, S., Vahabi, S., Torshabi, M., et al.[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 20 patients, deproteinized bovine bone mineral (DBBM) was found to promote more new bone formation in extraction sockets compared to irradiated cancellous allograft (ICA) and solvent-dehydrated allograft (SDA).

DBBM not only led to greater bone deposition but also retained more of its original graft material, suggesting it may be a superior choice for preserving extraction sockets in dental surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative histomorphometric analysis of extraction sockets healing implanted with bovine xenografts, irradiated cancellous allografts, and solvent-dehydrated allografts in humans. Lee, DW., Pi, SH., Lee, SK., et al.[2009]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10761198/

Surface demineralized freeze-dried bone allograft followed by ... The alveolar bone width and height at 15 months post-surgery were about 91% of the original values, with a slightly lower bone density, calculated using the ...

2. researchgate.net researchgate.net/publication/237001296_Evaluation_of_Healing_Following_Tooth_Extraction_With_Ridge_Preservation_Using_Cortical_Versus_Cancellous_Freeze-Dried_Bone_Allograft

Evaluation of Healing Following Tooth Extraction With ... Specifically, Borg et al., 2015 at the 18-20-week healing time point, reported 36% vital bone with a graft material of 70% freeze dried bone ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30161278/

Ridge preservation following tooth extraction using ... This study provides the first histologic comparison between the wound healing of FDBA and SDBA over a 12-week healing period in a ridge preservation ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/prd.12469

Alveolar ridge preservation: Complications and cost‐ ... We conclude that, among allogeneic and xenogeneic bone graft materials, increased expenditure does not translate into increased effectiveness of alveolar ridge ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667147621001667

Demineralized freeze-dried bone allograft vs biphasic ... Demineralized freeze-dried bone allograft with platelet rich plasma exhibited a superior quality of bone formation and a higher percentage of marrow spaces.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4095627/

A comparative evaluation of bovine-derived xenograft (Bio- ... The purpose of this study was to compare the efficacy of bovine-derived xenograft (Bio-Oss Collagen) and Type I collagen membrane (Bio-Gide)

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04955873

Ridge Preservation Using Xenogenic Bone Graft and Pre ... This study is a three-arm multicentric randomized trial that will evaluate the bone healing following ridge preservation of extraction sockets using two ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0929664618303991

Pure type-1 collagen application to third molar extraction ... This study assessed whether application of pure type-1 collagen to the third molar extraction socket can reduce post-operative pain score and duration and ...

9. mdpi.com mdpi.com/2079-4983/16/9/321

A Histological and Clinical Evaluation of Long-Term ... The purpose of the present report is to raise awareness about the long-term risks and possible late-onset complications associated with the use of bovine- ...

10. withpower.com withpower.com/trial/phase-tooth-loss-11-2018-37a36

Bio-Oss Collagen Graft for Tooth Loss · Info for Participants The purpose of this study is to clinically, radiographically and histologically evaluate the healing sequence of post-extraction sockets grafted with ...