Collagen Matrix + Growth Factor for Implant Complications
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.12345
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.12345
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.12678
Is the combination of Collagen Matrix and Growth Factor safe for human use?
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.13489
How is the treatment Collagen Matrix + rhPDGF-BB different from other treatments for implant complications?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
Post-operative Monitoring
Participants are monitored for post-operative pain and initial recovery
Follow-up
Participants are monitored for clinical, volumetric, ultrasonographic, and patient-reported outcomes
Treatment Details
Interventions
- Collagen Matrix
- rhPDGF-BB
Collagen Matrix is already approved in United States for the following indications:
- 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Harvard Medical School (HMS and HSDM)
Lead Sponsor