Bone Grafts for Jawbone Width Loss

Overseen By Eswar Kandaswamy, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Must not be taking: Bisphosphonates

Disqualifiers: Uncontrolled diabetes, Radiation to jaw, Immune compromise, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking bisphosphonates or have an immune compromise due to medication.

What data supports the effectiveness of the treatment Horizontal Ridge Augmentation with Demineralized Bone Allograft Layered with Xenograft?

Research shows that demineralized freeze-dried bone allograft (DFDBA) and freeze-dried bone allograft (FDBA) can lead to significant new bone formation, with studies reporting around 41% new bone growth in patients. DFDBA is also noted for its ability to maintain bone structure and support dental implants, making it a promising option for jawbone width loss. ^{1 2 3 4 5}

Is the use of bone grafts for jawbone width loss safe?

Research on bone grafts like demineralized freeze-dried bone allograft (DFDBA) and freeze-dried bone allograft (FDBA) shows they are generally safe for use in humans. Studies have shown successful outcomes in dental procedures, with no major safety concerns reported during follow-ups. ^{2 3 4 6 7}

How is the treatment for jawbone width loss using Horizontal Ridge Augmentation with Demineralized Bone Allograft and Xenograft different from other treatments?

This treatment is unique because it combines demineralized freeze-dried bone allograft (DFDBA) with xenograft bone, which can avoid the need for a second surgery to harvest bone from the patient. DFDBA is known for its ability to support new bone growth and maintain the shape of the jawbone, making it effective for dental implants and other oral surgeries. ^{1 2 3 4 6}

Research Team

Eswar Kandaswamy, BDS, MS

Principal Investigator

LSUHSC School of Dentistry

Eligibility Criteria

This trial is for adults over 18 needing bone augmentation before dental implants, who can follow up for 6-9 months, are in good health (ASA I or II), non-smokers, and able to undergo surgery. It's not for those with jaw radiation history, uncontrolled diabetes, HIV/hepatitis, pregnancy plans within 6 months, bisphosphonate use, untreated chronic periodontitis, failed prior implant at the site, immune issues or active infection/pathology at the treatment site.

Inclusion Criteria

Patients willing to be followed up for a period of 6-9 months

I am 18 years old or older.

I need bone grafting before getting dental implants.

Exclusion Criteria

I have had radiation treatment to my jaw.

My diabetes is not under control.

I have HIV or hepatitis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo horizontal ridge augmentation using DFDBA layered with xenograft particulate bone and a resorbable collagen membrane

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for surgical site healing and complications

8 weeks

3 visits (in-person) at 1-2, 3-5, and 6-8 weeks

Healing and Evaluation

Participants heal for 6-9 months, followed by CBCT scans to evaluate bone gain and graft shrinkage

6-9 months

1 visit (in-person) for CBCT scan

Implant Placement and Biopsy

Implant placement and optional bone core biopsy for histologic analysis

1 day

1 visit (in-person)

Treatment Details

Interventions

• Horizontal Ridge Augmentation with Demineralized Bone Allograft Layered with Xenograft (Bone Graft)

Trial Overview The study tests horizontal ridge augmentation using a mix of demineralized human bone (allograft) layered with animal-derived bone (xenograft) under a collagen membrane. The goal is to see how well this combination works for patients needing more bone width before getting dental implants.

Participant Groups

Group I: Xenograft and allograft Experimental Treatment 1 Intervention

The group will consist of patients receiving horizontal ridge augmentation using a combination of Demineralized Freeze Dried Bone Allograft (DFDBA) layered with xenograft particulate bone using a resorbable collagen membrane. The DFDBA will be used internally in contact with the native bone and xenograft will be layered buccal to it.

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

Geistlich Pharma

Collaborator

Trials

1

Recruited

20+

Findings from Research

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]

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]

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]

References

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

Histologic evaluation of mineralized and demineralized freeze-dried bone allograft for ridge and sinus augmentations. [2022]

2. 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]

3. 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]

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

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

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

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

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

Radiological and histological evaluation of horizontal ridge augmentation using corticocancellous freeze-dried bone allograft with and without autogenous bone: A randomized controlled clinical trial. [2020]

7. Iran pubmed.ncbi.nlm.nih.gov

A Comparision of Two Types of Decalcified Freeze-Dried Bone Allograft in Treatment of Dehiscence Defects around Implants in Dogs. [2021]