Clinical Trial: Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Clinical Trial of Safety and Efficacy of the Medical Item Collagen Plates With Hydroxyapol Inducing Angiogenesis, "Nukleostim", for Bone Tissue Regeneration

Brief Summary: The purpose of this study is to evaluate safety and efficacy of gene-activated matrix ("Nucleostim") for regeneration of bone tissue in maxillofacial area. Patients with congenital and acquired maxillofacial defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy will be included into the study.

Detailed Summary: All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Maxillofacial bone defects (formed after injuries, surgeries, excision of benign neoplasms and pseudotumors, teeth extraction, etc.) or areas of alveolar bone atrophy will be the filled by gene-activated matrix "Nucleostim". Safety and efficacy of implanted osteoplastic material will be assessed by physical examination, comprehensive laboratory tests, X-ray examination within 60 days after operation.
Sponsor: NextGen Company Limited

Current Primary Outcome: Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation [ Time Frame: 60 days ]

To determine the quantity of newly-formed bone tissue the morphometric parameters of regenerate will be measured on CT scan using special tools ("ROI", region of interest, etc.)

The morphometric parameters of bone regenerate include:

  • average density (in HU);
  • size (length, width, height) and volume.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain scores on the visual analog scale [ Time Frame: 60 days ]
  • Surgical failure rate [ Time Frame: 60 days ]
  • Adverse Events [ Time Frame: 60 days ]
  • Edema scores on the 0-10 Numeric Rating Scale [ Time Frame: 60 ]
    Level of edema at the surgical site will be assessed by physician using 0-10 Numeric Rating Scale.


Original Secondary Outcome: Same as current

Information By: NextGen Company Limited

Dates:
Date Received: November 11, 2014
Date Started: November 2014
Date Completion: December 2017
Last Updated: March 5, 2017
Last Verified: March 2016