Collagen Matrix + Growth Factor for Implant Complications

Overseen By Lorenzo Tavelli, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

Disqualifiers: Diabetes, HIV, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day (surgical procedure)

28 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims at comparing two different approaches for the treatment of implant esthetic complications (peri-implant soft tissue dehiscences): autogenous connective tissue graft vs collagen matrix + recombinant human platelet derived growth factor-BB

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a systemic condition that could affect wound healing, you may be excluded from the trial.

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Collagen Matrix + Growth Factor for Implant Complications is an effective treatment?

The available research shows that Collagen Matrix + Growth Factor, specifically using recombinant human platelet-derived growth factor (rhPDGF-BB), is effective in promoting wound healing and bone regeneration. Studies demonstrate that this treatment can enhance the healing process by encouraging the growth of new blood vessels and the migration of cells that are important for tissue repair. For example, in animal studies, the use of rhPDGF-BB led to increased cell infiltration and new blood vessel formation, which are crucial for healing. Additionally, the treatment has been shown to help regenerate bone and soft tissue, making it a promising option for implant complications. Compared to treatments without growth factors, this approach offers faster and more predictable healing, which can be beneficial for patients needing timely recovery. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Collagen Matrix + Growth Factor for Implant Complications?

Research shows that the growth factor rhPDGF-BB, a key component of the treatment, helps in wound healing and bone regeneration by promoting cell growth and blood vessel formation. Studies have demonstrated its effectiveness in improving healing in periodontal and skin defects, suggesting it may also be beneficial for implant complications. ^{1 2 3 4 5}

What safety data is available for Collagen Matrix + Growth Factor treatment?

The safety data for the treatment involving recombinant human platelet-derived growth factor-BB (rhPDGF-BB) in combination with collagen and beta-tricalcium phosphate (β-TCP) indicates that it is biocompatible and has no systemic or local toxicity. Preclinical toxicology studies have shown that rhPDGF-BB, either alone or with β-TCP or collagen, does not cause dermal sensitization, irritation, intramuscular tissue responses, pyrogenicity, genotoxicity, or hemolytic effects. This supports its safe use in enhancing wound healing and bone regeneration. ^{1 2 6 7 8}

Is the combination of Collagen Matrix and Growth Factor safe for human use?

Research indicates that the combination of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) with collagen and other materials is generally safe, showing no systemic or local toxicity in studies. This suggests it is biocompatible and safe for enhancing wound healing in patients. ^{1 2 6 7 8}

Is the drug Collagen Matrix, rhPDGF-BB a promising treatment for implant complications?

Yes, the drug Collagen Matrix, rhPDGF-BB is promising for implant complications. It helps in wound healing and bone regeneration by promoting the growth of new cells and blood vessels. This can lead to better healing of tissues and bones, making it a valuable option for treating implant complications. ^{1 3 4 8 9}

How is the treatment Collagen Matrix + rhPDGF-BB different from other treatments for implant complications?

This treatment is unique because it combines a collagen matrix with rhPDGF-BB, a synthetic growth factor that enhances wound healing and bone regeneration by promoting cell growth and new blood vessel formation, which is not typically seen in standard treatments for implant complications. ^{1 3 4 8 9}

Research Team

Lorenzo Tavelli, DDS, MS

Principal Investigator

Harvard School of Dental Medicine, Boston, USA

Eligibility Criteria

This trial is for adults over 18 who have good oral hygiene and are in general good health. They should have a single dental implant in the front of their mouth with peri-implant soft tissue dehiscences, which they want to treat.

Inclusion Criteria

Presence of single dental implant in the anterior area (from the first right premolar to the first left premolar) showing a PSTD, with the subjects searching for treatment of this condition

I am 18 years old or older.

My gums and overall health are good.

Exclusion Criteria

I had soft tissue grafting at the implant site with problems in the last 6 months.

Patients pregnant or attempting to get pregnant (self-reported)

I cannot undergo surgery due to health risks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an autogenous connective tissue graft or a collagen matrix with rhPDGF-BB for the treatment of peri-implant soft tissue dehiscences

1 day (surgical procedure)

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative pain and initial recovery

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for clinical, volumetric, ultrasonographic, and patient-reported outcomes

12 months

Multiple visits (in-person) at 3, 6, and 12 months

Treatment Details

Interventions

• Collagen Matrix
• rhPDGF-BB

Trial Overview The study compares two treatments for aesthetic issues around dental implants: one uses a collagen matrix with growth factor (rhPDGF-BB), and the other uses tissue from the patient's own body.

Participant Groups

Group I: Collagen matrix + rhPDGF-BB Experimental Treatment 1 Intervention

Xenogeneic cross-linked collagen matrix + recombinant human platelet-derived growth factor-BB

Group II: Connective tissue graft Active Control 1 Intervention

Autogenous connective tissue graft harvested from the palate as a free gingival graft and then de-epithelialized

Collagen Matrix is already approved in United States for the following indications:

Approved in United States as Collagen Matrix for:

• Management of moderately to heavily exudating wounds
• Control of minor bleeding
• Pressure ulcers
• Venous stasis ulcers
• Diabetic ulcers
• Acute wounds
• Partial-thickness burns
• Augmentation or reconstructive treatment of alveolar ridge
• Filling of infrabony periodontal defects
• Filling of defects after root apicoectomy and cystectomy
• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

Findings from Research

The growth-factor enhanced matrix (GEM) is a new clinical technology that combines recombinant human platelet-derived growth factor (rhPDGF-BB) with a bone scaffold, designed to enhance wound healing and bone regeneration.

Clinical and animal studies show that GEM effectively promotes wound healing, bone regeneration, and improves gingival attachment in difficult periodontal and peri-implant defects, highlighting its potential as a powerful treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new era in periodontal and periimplant regeneration: use of growth-factor enhanced matrices incorporating rhPDGF. Lynch, SE., Wisner-Lynch, L., Nevins, M., et al.[2018]

In a study involving 17 patients with 40 bilateral gingival recession defects, both treatments using acellular dermal matrix (ADM) with and without recombinant human platelet-derived growth factor (rhPDGF) showed significant root defect coverage gains over 6 months, with 69.0% for the rhPDGF group and 76.7% for the control group.

Despite some early healing advantages observed in the rhPDGF group, there were no statistically significant differences in overall root defect coverage or healing outcomes between the two treatment methods after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of root defect coverage using an acellular dermal matrix with and without a recombinant human platelet-derived growth factor. Carney, CM., Rossmann, JA., Kerns, DG., et al.[2018]

The recombinant BB homodimer of platelet-derived growth factor (rPDGF-BB) significantly enhances cellular infiltration and vascularization in collagen-based dermal substitutes, as shown in a study with rats where doses of up to 4 micrograms were tested.

At the highest dose, rPDGF-BB led to increased fibroblast infiltration within 3 days and improved capillary formation by 7 days, which correlated with better survival rates of skin grafts placed on the treated sponges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The enhancement of cellular infiltration and vascularisation of a collagenous dermal implant in the rat by platelet-derived growth factor BB. Royce, PM., Kato, T., Ohsaki, K., et al.[2019]

The use of recombinant PDGF-BB (rPDGF-BB) significantly enhances the recruitment and proliferation of mesenchymal cells, leading to the formation of new tissue around vascular bundles, as demonstrated in a rat model.

When combined with a skin graft, rPDGF-BB treatment resulted in the development of functional soft tissue appendages that showed increased blood vessel formation and collagen deposition, suggesting its potential for clinical applications in tissue repair and regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De novo generation of permanent neovascularized soft tissue appendages by platelet-derived growth factor. Khouri, RK., Hong, SP., Deune, EG., et al.[2018]

Recombinant human platelet-derived growth factor (rhPDGF-BB) combined with bone graft materials can effectively regenerate periodontal tissue by promoting cellular migration and proliferation, leading to improved healing outcomes.

The use of rhPDGF-BB not only accelerates soft tissue healing at surgical sites but also allows for quicker prosthetic care and earlier resumption of plaque control by patients, enhancing overall recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using recombinant platelet-derived growth factor to facilitate wound healing. Rosen, PS.[2018]

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) has been shown to be biocompatible and safe, with no systemic or local toxicity observed in extensive testing, making it a promising option for enhancing wound healing.

The study evaluated the effects of rhPDGF-BB alone and in combination with beta-tricalcium phosphate or collagen, confirming its safety in various applications related to tissue repair and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Toxicology Studies of Recombinant Human Platelet-Derived Growth Factor-BB Either Alone or in Combination with Beta-Tricalcium Phosphate and Type I Collagen. Young, CS., Bradica, G., Hart, CE., et al.[2021]

The study demonstrated that injecting recombinant human platelet-derived growth factor-BB (rhPDGF-BB) combined with a collagen/β-tricalcium phosphate paste significantly increased bone mineral density and improved bone morphology in the lumbar vertebrae of aged female baboons, indicating its potential efficacy for bone regeneration.

No local or systemic adverse effects were observed during the study, suggesting that the treatment is safe for use in this model, although it is not yet FDA approved for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous injection of augment injectable bone graft (rhPDGF-BB and β-tricalcium phosphate [β-TCP]/bovine type I collagen matrix) increases vertebral bone mineral density in geriatric female baboons. Perrien, DS., Young, CS., Alvarez-Urena, PP., et al.[2018]

Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) shows promise in enhancing tendon and ligament healing by promoting the recruitment and proliferation of tenogenic cells, which can lead to better tissue repair.

Preclinical studies indicate that rhPDGF-BB improves the structural and functional properties of healing tendons and ligaments, potentially offering a more effective treatment option compared to traditional methods that often result in inferior scar tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative tendon and ligament healing: opportunities with recombinant human platelet-derived growth factor BB-homodimer. Hee, CK., Dines, JS., Solchaga, LA., et al.[2018]

In a study using rat models, PDGF-BB significantly enhanced granulation tissue formation, leading to a 34% increase in collagen accumulation and higher levels of RNA and other important tissue components when administered at 500 ng.

While PDGF-AA showed some effectiveness in increasing RNA levels in vitro, it was less effective in promoting granulation tissue development in vivo compared to PDGF-BB, indicating that PDGF-BB is the more potent growth factor for wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of homodimeric isoforms of platelet-derived growth factor (PDGF-AA and PDGF-BB) on wound healing in rat. Lepistö, J., Laato, M., Niinikoski, J., et al.[2019]

References

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

A new era in periodontal and periimplant regeneration: use of growth-factor enhanced matrices incorporating rhPDGF. [2018]

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

A comparative study of root defect coverage using an acellular dermal matrix with and without a recombinant human platelet-derived growth factor. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The enhancement of cellular infiltration and vascularisation of a collagenous dermal implant in the rat by platelet-derived growth factor BB. [2019]

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

De novo generation of permanent neovascularized soft tissue appendages by platelet-derived growth factor. [2018]

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

Using recombinant platelet-derived growth factor to facilitate wound healing. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Preclinical Toxicology Studies of Recombinant Human Platelet-Derived Growth Factor-BB Either Alone or in Combination with Beta-Tricalcium Phosphate and Type I Collagen. [2021]

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

Percutaneous injection of augment injectable bone graft (rhPDGF-BB and β-tricalcium phosphate [β-TCP]/bovine type I collagen matrix) increases vertebral bone mineral density in geriatric female baboons. [2018]

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

Regenerative tendon and ligament healing: opportunities with recombinant human platelet-derived growth factor BB-homodimer. [2018]

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

Effects of homodimeric isoforms of platelet-derived growth factor (PDGF-AA and PDGF-BB) on wound healing in rat. [2019]