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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for treating issues with dental implants, specifically when the gum tissue around the implant appears abnormal. One treatment uses a graft taken from the roof of the mouth, while the other uses a special collagen matrix combined with a growth factor, specifically rhPDGF-BB, which aids healing. The goal is to determine which method better improves the appearance of the gum tissue. This trial may suit individuals with a single dental implant showing visible gum issues who are generally healthy and free from ongoing gum disease. As an unphased trial, it offers a unique opportunity to explore innovative treatments for dental implant issues.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a collagen matrix with a special growth factor (rhPDGF-BB) is generally safe. In past studies, this combination effectively treated gum and bone problems. Participants did not experience major issues, and the treatment was well-tolerated, with no serious side effects reported.

Overall, those considering this treatment can find reassurance in past research supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a collagen matrix combined with recombinant human platelet-derived growth factor-BB (rhPDGF-BB) for implant complications because it offers a unique approach by promoting tissue regeneration. Unlike traditional treatments, which typically involve autogenous grafts harvested from the patient's palate, this method uses a xenogeneic collagen matrix, which could reduce the need for invasive grafting procedures. Additionally, the inclusion of rhPDGF-BB enhances healing by stimulating cell growth and new blood vessel formation, potentially speeding up recovery and improving outcomes.

What evidence suggests that this trial's treatments could be effective for implant complications?

Research has shown that using a collagen matrix with a special growth factor called rhPDGF-BB can help treat problems with dental implants. In this trial, one group of participants will receive the combination of collagen matrix and rhPDGF-BB. Studies have found that rhPDGF-BB speeds up healing and improves results in dental work by aiding tissue growth and repair. When combined with a collagen matrix, it has succeeded in procedures like sinus lifts, suggesting it might also aid healing around implants. Early evidence indicates that this combination could provide better cosmetic results than some traditional methods. This treatment enhances the body's natural healing processes to address complications. ^{2 3 4 6 7}

Who Is on the Research Team?

Lorenzo Tavelli, DDS, MS

Principal Investigator

Harvard School of Dental Medicine, Boston, USA

Are You a Good Fit for This Trial?

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

My gums and overall health are good.

Full-mouth plaque score and full-mouth bleeding score ≤ 20% (measured at four sites per tooth)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37870470/

Human platelet-derived growth factor-BB (rhPDGF-BB) with ... The use of rhPDGF-BB and a collagen matrix in a sinus lift procedure emerges as a practical therapeutic option when grafting might lack predictability.

2. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/full/10.1002/cap.10268

Human platelet‐derived growth factor‐BB (rhPDGF‐BB) with ... The use of rhPDGF-BB and a collagen matrix in a sinus lift procedure emerges as a practical therapeutic option when grafting might lack ...

3. researchgate.net researchgate.net/publication/374934450_Human_platelet-derived_growth_factor-BB_rhPDGF-BB_with_collagen_matrix_for_sinus_elevation_without_using_a_bone_graft

(PDF) Human platelet‐derived growth factor‐BB (rhPDGF‐ ... Key points The use of rhPDGF‐BB and a collagen matrix in a sinus lift procedure emerges as a practical therapeutic option when grafting might ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9796054/

Recombinant human platelet‐derived growth factor ... rhPDGF enhances the clinical, volumetric, and aesthetic outcomes of MAGRs above the results achieved with CAF + CCM alone (ClinicalTrials.gov NCT04462237).

5. withpower.com withpower.com/trial/phase-implant-complication-9-2022-cd6eb

Collagen Matrix + Growth Factor for Implant Complications Preclinical toxicology studies have shown that rhPDGF-BB, either alone or with β-TCP or collagen, does not cause dermal sensitization, irritation, intramuscular ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7961612/

Recombinant Human Platelet–Derived Growth Factor rhPDGF is a safe and effective approach for the treatment of intrabony and furcation periodontal defects and gingival recession.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06634030

NCT06634030 | Evaluating rhPDGF-BB-Enhanced Wound ... Preclinical and clinical data suggest that rhPDGF may be a viable therapeutic strategy to augment the reconstruction of these complex surgical wounds by ...