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

Trial Summary

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.

What data supports the effectiveness of the treatment CEBX for bone grafts in tooth extractions?

Research shows that components like demineralized freeze-dried bone allograft (DFDBA) and bovine-derived bone xenograft have been successfully used in dental surgeries to promote new bone growth and preserve extraction sockets. These materials help in forming new bone and integrating well with existing bone, which suggests they could be effective in similar treatments like CEBX. ^{1 2 3 4 5}

Is the use of bone grafts for tooth extractions safe?

Research indicates that demineralized freeze-dried bone allografts (DFDBA) and freeze-dried bone allografts (FDBA) are generally safe for use in humans, as they integrate well with new bone and show no significant inflammatory reactions. ^{1 3 4 6 7}

How is the treatment CEBX, FDBA different from other treatments for bone grafts after tooth extractions?

The treatment using CEBX and FDBA is unique because it combines collagen-enriched bovine xenograft and freeze-dried bone allografts, which are known for their potential to promote new bone growth and maintain the shape of the jawbone after tooth extraction. This combination may offer enhanced bone healing and stability compared to other treatments. ^{1 2 3 4 6}

What is the purpose of this trial?

The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material. The study aims to examine the following main questions: * Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing * Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated. The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as: * Demographic information * Clinical information from intraoral photographs * Radiographic information from cone beam computed tomography and periapical radiographs.

Research Team

Elli Anna Kotsailidi, DDS, MS

Principal Investigator

Eastman Institute for Oral Health, University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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]

References

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

Gene Expression and Microcomputed Tomography Analysis of Grafted Bone Using Deproteinized Bovine Bone and Freeze-Dried Human Bone. [2019]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

In vitro assay for osteoinductive activity of different demineralized freeze-dried bone allograft. [2022]

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

Histologic evaluation of human extraction sockets treated with demineralized freeze-dried bone allograft (DFDBA) and cell occlusive membrane. [2008]

4. 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]

5. United States 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. [2009]

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

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

7. 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]