Bone Graft with rhPDGF vs. Saline for Dental Implants

Overseen By Hussein Basma, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Smokers, Systemic pathologies, Poor compliance, others

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

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

Compensation: Varies

Number of Visits: 4

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare two techniques to achieve increase in ridge dimensions as a preparation for dental implants using a resorbable barrier membrane and bone particulate allogenic graft hydrated with saline or a growth factor called Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Bone Graft with rhPDGF vs. Saline for Dental Implants?

Research indicates that allogenic bone grafts, like those used in the treatment, have shown potential in bone regeneration, particularly in challenging areas, and can support bone healing effectively. Additionally, the use of growth factors such as rhPDGF-BB in combination with bone grafts may enhance the regenerative process, as seen in other clinical contexts. ^{1 2 3 4 5}

Is the bone graft with rhPDGF safe for humans?

A clinical trial on rhPDGF in foot surgeries indicated that it was necessary to assess both efficacy and safety before further studies, suggesting some initial safety evaluation. Additionally, a study on bone graft substitutes, including those with rhPDGF, showed they can cause an inflammatory response, which is a common reaction to implanted materials. ^{2 6 7 8 9}

How does the treatment using bone allograft particles hydrated with saline differ from other treatments for dental implants?

This treatment is unique because it combines bone allograft particles with recombinant human platelet-derived growth factor (rhPDGF), which is known to enhance bone regeneration by promoting cell growth and healing. Unlike traditional bone grafts, this approach uses a growth factor to potentially improve the integration and success of dental implants. ^{2 7 10 11 12}

Eligibility Criteria

This trial is for adults over 18 who are patients at the UAB Dental School, need dental implants due to insufficient alveolar ridge width, and can understand the consent form. It's not for smokers, those with conditions that affect healing or oral surgery risks, non-English speakers, minors, or individuals with poor compliance risk.

Inclusion Criteria

Able to read and understand informed consent document

Must be a patient of the UAB Dental School

Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan)

Exclusion Criteria

I do not have any health conditions that would interfere with surgery or healing.

I do not speak English.

Smokers/tobacco users (>10 cigarettes/day)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ridge Augmentation Treatment

Participants receive ridge augmentation using allograft particles hydrated with either rhPDGF or saline, covered with a resorbable barrier membrane

20 minutes for hydration, followed by grafting

1 visit (in-person)

Implant Placement and Biopsy

Bone core biopsies are harvested at the time of implant placement to analyze healing differences

4 months after ridge augmentation

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic comparisons and histomorphometric evaluations

4 months

2 visits (in-person)

Treatment Details

Interventions

• Allograft particles hydrated with saline
• Recombinant Human Platelet-Derived Growth Factor

Trial Overview The study compares two methods of increasing bone ridge dimensions before dental implant placement: one using a graft hydrated with saline and another using Recombinant Human Platelet-Derived Growth Factor (rhPDGF).

Participant Groups

Group I: Allograft particles hydrated with rhPDGF Experimental Treatment 1 Intervention

Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.

Group II: Allograft particles hydrated in a conventional way with saline. Active Control 1 Intervention

Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.

Allograft particles hydrated with saline is already approved in United States, European Union for the following indications:

Approved in United States as Bone Allograft for:

• Dental implant site preparation
• Bone repair and regeneration

Approved in European Union as Allogenic Bone Graft for:

• Bone repair and regeneration
• Orthopedic procedures

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a study involving 20 patients undergoing sinus augmentation with a novel freeze-dried allogenic bone substitute, all patients experienced satisfactory healing without complications, indicating the safety of this grafting material.

Histologic analysis showed that the allograft led to the formation of well-organized lamellar bone, with a mean vital bone percentage of 23.02%, supporting its efficacy as a suitable grafting option for sinus augmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histologic outcomes after the use of a novel allograft for maxillary sinus augmentation: a case series. Avila, G., Neiva, R., Misch, CE., et al.[2010]

There are 87 alloplastic bone graft products approved in the United States, 10 in Japan, and 36 in Korea, with the most common types being hydroxyapatite, β-tricalcium phosphate, and biphasic calcium phosphate, indicating a wide variety of options available for bone regeneration.

The review suggests that alloplastic bone substitutes may soon become the preferred choice over autologous bone due to their safety, standardized quality, and potential for enhanced osteoconductive and osteoinductive properties, especially when combined with growth factors or cell transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alloplastic Bone Substitutes for Periodontal and Bone Regeneration in Dentistry: Current Status and Prospects. Fukuba, S., Okada, M., Nohara, K., et al.[2021]

In a study involving 84 patients and 247 dental implants, peri-implant bone loss at implants placed in alveolar sockets filled with a bone graft and platelet concentrates was found to be similar to that of implants placed in native bone after 6 and 12 months.

Overall, there were no significant differences in bone loss between the two groups, suggesting that using DFDBA and platelet concentrates for socket preservation does not negatively impact bone stability compared to native bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-Implant Bone Loss at Implants Placed in Preserved Alveolar Bone Versus Implants Placed in Native Bone: A Retrospective Radiographic Study. Quoc, JB., Vang, A., Evrard, L.[2022]

The innovative partially demineralized allogenic bone graft paste demonstrated superior cell attachment and osteoblastic differentiation compared to traditional allogenic bone particles, indicating enhanced regenerative potential.

In vivo studies showed that the bone paste not only supported bone healing in a guide bone regeneration model but also exhibited significant bone-forming ability in a critical-size defect model in rats, suggesting it could be a promising alternative for clinical bone regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A partially demineralized allogeneic bone graft: in vitro osteogenic potential and preclinical evaluation in two different intramembranous bone healing models. Tournier, P., Guicheux, J., Paré, A., et al.[2021]

In a pilot study involving 11 subjects, the use of decalcified freeze-dried bone allografts in treating periodontal defects led to increased levels of inflammatory markers, specifically prostaglandin E(2) and bone-specific type 1 collagen, within the first 2 weeks post-surgery.

The study found a positive correlation between the levels of prostaglandins and changes in bone height over 6 months, suggesting that while the inflammatory response is stimulated by the grafts, it may play a role in bone healing that warrants further investigation regarding the effects of post-operative treatments that inhibit prostaglandins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inflammatory mediator release following bone grafting in humans: a pilot study. Preston, RD., Meinberg, TA., Payne, JB., et al.[2016]

In a study involving 34 subjects undergoing maxillary sinus augmentation, both solvent dehydrated human allograft (SDHA) and freeze-dried human allograft (FDHA) were found to be effective in promoting bone formation when combined with autogenous bone.

While there was no significant difference in the amount of mineralized tissue between SDHA and FDHA, FDHA showed higher cellular activity, including more osteoblasts and fibroblasts, indicating potentially faster bone turnover.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular, Vascular, and Histomorphometric Outcomes of Solvent-Dehydrated vs Freeze-Dried Allogeneic Graft for Maxillary Sinus Augmentation: A Randomized Case Series. Monje, A., O'Valle, F., Monje-Gil, F., et al.[2022]

In a study involving 60 patients undergoing hindfoot or midfoot fusion, the synthetic bone graft material Augment Bone Graft (rhPDGF/TCP) was found to be safe, with no serious adverse events reported over a 36-week follow-up period.

At 36 weeks, 75% of patients showed moderate to complete bone bridging at the fusion sites, indicating that rhPDGF/TCP is effective in promoting bone healing and supports further research comparing it to traditional autograft bone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. Daniels, T., DiGiovanni, C., Lau, JT., et al.[2016]

This study evaluated the inflammatory response to four different bone graft substitutes using a murine air pouch model, revealing that all substitutes caused significant inflammation compared to controls, indicating a safety concern.

Among the materials tested, a coralline hydroxyapatite product showed a low inflammatory response, suggesting it may be a safer option compared to demineralized bone matrix products, which elicited higher inflammation levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of the inflammatory response to four commercial bone graft substitutes using a murine biocompatibility model. Markel, DC., Guthrie, ST., Wu, B., et al.[2021]

In a study involving 14 adult rabbits, lyophilized allogeneic bone from both skull and tibia origins showed similar patterns of bone regeneration in a cranioplasty model, indicating that both types of bone can be effectively used for healing.

The lyophilized bone allografts demonstrated low osteoinductive potential, suggesting that while they support bone healing, they may not significantly stimulate new bone formation compared to other materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative response to membranous and enchondral lyophilized allogeneic bone in rabbit skull defects. Isaksson, S., Alberius, P., Klinge, B., et al.[2019]

The off-label use of rhPDGF-BB combined with bone allografts for dental procedures has shown promising clinical outcomes in various cases, including ridge preservation and sinus augmentation, suggesting it may enhance bone regeneration.

Clinical observations indicate that using rhPDGF-BB with particulate bone allografts can be consistent with good clinical practice, but further controlled trials are needed to confirm its effectiveness compared to other grafting materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue engineering with recombinant human platelet-derived growth factor BB for implant site development. Nevins, ML., Reynolds, MA.[2018]

Highly purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) is safe and effective when used with osteoconductive matrices for treating moderate to severe periodontal intrabony defects, as shown in human studies.

In a case series involving rhPDGF-BB combined with mineralized freeze-dried bone allograft (FDBA), complete bone fill was observed in severe periodontal defects up to 11 months post-treatment, indicating strong regenerative potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical results using recombinant human platelet-derived growth factor and mineralized freeze-dried bone allograft in periodontal defects. Nevins, M., Hanratty, J., Lynch, SE.[2018]

The case series involved two patients who underwent vertical ridge augmentation using titanium mesh and recombinant human platelet-derived growth factor BB (rhPDGF-BB), showing successful clinical outcomes without postoperative complications.

The combination of titanium mesh and rhPDGF-BB effectively facilitated guided bone regeneration, allowing for successful implant placement and improved three-dimensional esthetic architecture in severely resorbed alveolar ridges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical combined approach for alveolar ridge augmentation with titanium mesh and rhPDGF-BB: a 3-year clinical case series. De Angelis, N., De Lorenzi, M., Benedicenti, S.[2018]

References

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

Clinical and histologic outcomes after the use of a novel allograft for maxillary sinus augmentation: a case series. [2010]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Alloplastic Bone Substitutes for Periodontal and Bone Regeneration in Dentistry: Current Status and Prospects. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Peri-Implant Bone Loss at Implants Placed in Preserved Alveolar Bone Versus Implants Placed in Native Bone: A Retrospective Radiographic Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A partially demineralized allogeneic bone graft: in vitro osteogenic potential and preclinical evaluation in two different intramembranous bone healing models. [2021]

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

Inflammatory mediator release following bone grafting in humans: a pilot study. [2016]

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

Cellular, Vascular, and Histomorphometric Outcomes of Solvent-Dehydrated vs Freeze-Dried Allogeneic Graft for Maxillary Sinus Augmentation: A Randomized Case Series. [2022]

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

Prospective clinical pilot trial in a single cohort group of rhPDGF in foot arthrodeses. [2016]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Characterization of the inflammatory response to four commercial bone graft substitutes using a murine biocompatibility model. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Regenerative response to membranous and enchondral lyophilized allogeneic bone in rabbit skull defects. [2019]

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

Tissue engineering with recombinant human platelet-derived growth factor BB for implant site development. [2018]

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

Clinical results using recombinant human platelet-derived growth factor and mineralized freeze-dried bone allograft in periodontal defects. [2018]

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

Surgical combined approach for alveolar ridge augmentation with titanium mesh and rhPDGF-BB: a 3-year clinical case series. [2018]