Bone Grafts for Jawbone Width Loss

Overseen By Vinayak Joshi, BDS, MS, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to address jawbone width loss using a combination of bone graft materials, specifically Horizontal Ridge Augmentation with Demineralized Bone Allograft layered with Xenograft. The goal is to evaluate how well these materials work together to rebuild the jawbone before dental implants. It targets individuals who need this treatment, can undergo surgery, do not smoke, and have no history of uncontrolled diabetes or jaw radiation. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, providing an opportunity to benefit from established research.

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 is the safety track record for the horizontal ridge augmentation with demineralized bone allograft layered with xenograft?

Research has shown that treatments using a mix of specially prepared bone from donors and animal sources are generally well-tolerated. In studies focused on widening the jawbone, these materials did not cause major problems. For example, one study found no significant differences in results for patients receiving similar treatments, suggesting the materials are safe for people.

Moreover, since this trial is in its fourth phase, extensive safety information is already available. Earlier phases focused on ensuring the treatment's safety before reaching this stage. While individual health conditions should be considered, current research indicates the treatment is generally safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about this treatment for jawbone width loss because it combines two different types of bone grafts: Demineralized Freeze Dried Bone Allograft (DFDBA) and xenograft particulate bone. Unlike standard treatments that might use just one type of graft, this combination aims to enhance bone regeneration by layering the DFDBA internally with the native bone and placing the xenograft on the outer side. This method may provide a more robust and stable framework for new bone growth, potentially leading to better and longer-lasting results. Additionally, the use of a resorbable collagen membrane helps integrate the grafts into the jawbone more effectively, which could improve healing times and outcomes.

What evidence suggests that this treatment might be an effective treatment for jawbone width loss?

Research has shown that using a mix of special bone materials from donors and animals can effectively widen the jawbone. These materials support new bone cell growth by providing a structural framework. In this trial, participants will undergo horizontal ridge augmentation using a combination of Demineralized Freeze-Dried Bone Allograft (DFDBA) layered with xenograft particulate bone. Studies have demonstrated that these materials are effective in dental procedures that increase bone size, such as ridge augmentation. Specifically, one study found that they yield similarly good results when used for back teeth areas. This treatment has already proven effective for improving bone width in dental applications. ^{2 6 7 8 9}

Who Is on the Research Team?

Eswar Kandaswamy, BDS, MS

Principal Investigator

LSUHSC School of Dentistry

Are You a Good Fit for This Trial?

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 need bone grafting before getting dental implants.

I can safely undergo surgery with IV sedation.

Exclusion Criteria

I have had radiation treatment to my jaw.

My diabetes is not under control.

I have HIV or hepatitis.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Horizontal Ridge Augmentation with Demineralized Bone Allograft Layered with Xenograft

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.

How Is the Trial Designed?

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.

Horizontal Ridge Augmentation with Demineralized Bone Allograft Layered with Xenograft is already approved in United States, European Union for the following indications:

Approved in United States as Demineralized Freeze-Dried Bone Allograft (DFDBA) for:

• Alveolar ridge augmentation
• Socket preservation
• Guided bone regeneration
• Maxillary sinus augmentation
• Treatment of peri-implant defects

Approved in European Union as Demineralized Freeze-Dried Bone Allograft (DFDBA) for:

• Alveolar ridge augmentation
• Socket preservation
• Guided bone regeneration
• Maxillary sinus augmentation
• Treatment of peri-implant defects

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+

Published Research Related to This Trial

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 93 patients who underwent maxillary sinus or ridge augmentations, both demineralized freeze-dried bone allograft (DFDBA) and freeze-dried bone allograft (FDBA) showed similar efficacy in promoting new bone formation, with mean percentages of 41.89% and 41.74% respectively.

The analysis of bone biopsies taken 6 to 36 months post-grafting revealed no significant difference in new bone formation between the two types of grafts, indicating that both are effective options for bone augmentation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Histologic evaluation of mineralized and demineralized freeze-dried bone allograft for ridge and sinus augmentations. Cammack, GV., Nevins, M., Clem, DS., et al.[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]

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 42 patients, both corticocancellous freeze-dried bone allograft (FDBA) alone and a combination of FDBA with autogenous bone (AB) showed significant horizontal ridge width gain after 6 months, indicating their efficacy for ridge augmentation.

However, adding autogenous bone to FDBA did not significantly improve the quality or quantity of new bone formation, suggesting that FDBA alone is sufficient for effective ridge augmentation.

NCBI (Pubmed)

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. Hashemipoor, M., Asghari, N., Mohammadi, M., et al.[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]

In a study involving three dogs, the use of decalcified freeze-dried bone allograft (DFDBA) did not significantly improve bone-to-implant contact around dental implants compared to a control group, indicating that DFDBA may not enhance bone formation in this context.

All implants successfully osseointegrated after 4 months, and the Implant Stability Quotient was found to be a reliable method for assessing implant stability, with a strong correlation to histomorphometric measurements.

NCBI (Pubmed)

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. Abed, AM., Pestekan, RH., Yaghini, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4040931/

Mechanisms of Guided Bone Regeneration: A Review - PMC Guided bone regeneration can be achieved with using particulate autogenous bone grafts, allografts, xenografts, or alloplasts grafting materials.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8158510/

Bone Grafts and Substitutes in Dentistry: A Review of Current ... This review will critically present the various dental bone graft and substitute materials that have been used to achieve a successful dental implant.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0020653924002028

Alveolar Ridge Preservation Using a Collagenated Xenograft This study sought to evaluate the efficacy of cancellous bovine bone mineral granules and 10% porcine collagen (deproteinized bovine bone mineral with collagen ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/clr.13911

Ridge preservation in molar sites comparing xenograft ... Ridge preservation in molar sites using a mineralized allograft or xenograft provides similar dimensional and histomorphometrical results after 5 months.

5. researchgate.net researchgate.net/publication/376679117_Horizontal_ridge_augmentation_with_particulate_cortico-cancellous_freeze-dried_bone_allograft_alone_or_combined_with_injectable-platelet_rich_fibrin_in_a_randomized_clinical_trial

Horizontal ridge augmentation with particulate cortico ... Objectives The objective of this study is to assess the effectiveness of horizontal ridge augmentation using FDBA in combination with injectable-platelet ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382196/

Horizontal Alveolar Ridge Augmentation with Xenogenic ... No significant difference could be identified in short-term implant treatment outcome following horizontal alveolar ridge augmentation using xenogenic block.

7. mdpi.com mdpi.com/1996-1944/8/6/2953

Bone Replacement Materials and Techniques Used for ... This narrative review focuses on existing techniques, natural tissues and synthetic biomaterials commonly used to achieve vertical bone height gain.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20545553/

Horizontal ridge augmentation utilizing a composite graft of ... Data were obtained from 73 consecutively treated lateral ridge augmentations performed on 67 partial and/or completely edentate patients. Clinical data ( ...

9. opendentistryjournal.com opendentistryjournal.com/VOLUME/8/PAGE/66/FULLTEXT/

Ridge Preservation for Implant Therapy: a Review of the ... This review will explore the evidence behind each technique and their efficacy in accomplishing site preparation.