Gene-activated Matrix for Bone Tissue Repair in Maxillofacial Surgery

Not Applicable

• Conditions: Disorders of Teeth and Jaw; Jaw Fractures; Maxillofacial Bone Deformities; Maxillofacial Bone Defects; Alveolar Bone Atrophy; Bone Neoplasm, Benign
• Interventions: Device: Gene-activated matrix "Nucleostim"

• Registration Number: NCT02293031
• Lead Sponsor: NextGen Company Limited

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 Description

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-18
• Status Verified: 2016-03
• Last Update Submitted: 2017-03-05
• Last Update Posted: 2017-03-07
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• obtained voluntary informed consent for participation in the clinical study;
• congenital and acquired maxillofacial bone defects (sockets of extracted teeth, bone defects after injuries, surgeries, excision of benign neoplasms and pseudotumors, etc.) or alveolar bone atrophy.

Exclusion Criteria

• not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
• decompensated chronic visceral diseases;
• clinically significant laboratory abnormalities;
• HIV, HBV and HCV antibodies in serum;
• alcohol consumption within 4 days prior the study;
• history of drug addiction;
• participation in other clinical studies (or administration of study products) within 3 months prior the study;
• conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
• malignancies including post-surgical period with chemo- and (or) radiation therapy);
• vascular malformations;
• pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gene-activated matrix "Nucleostim"	Gene-activated matrix "Nucleostim"	Implantation of gene-activated matrix "Nucleostim" into the bone defects or sites of bone atrophy

Primary Outcome Measures

Name	Time	Method
Quantity of newly-formed bone tissue in the field of gene-activated matrix implantation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Moscow State University of Medicine and Dentistry; 🇷🇺 Moscow, Russian Federation

Burnasyan Federal Medical Biophysical Center; 🇷🇺 Moscow, Russian Federation