Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation

Comparative Study of Gene-activated Bone Substitute Based on Octacalcium Phosphate and Plasmid DNA Encoding VEGFA Gene and Xenogenic Bone Matrix for Alveolar Ridge Augmentation: an Open-label Randomized Controlled Trial

The study aim is to compare the effectiveness of two bone substitutes, the gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene and xemogenic deproteinized bone matrix, mixed with shredded autobone in vertical and horizontal augmentation of alveolar ridge before dental implantation

Study Overview

• Status: Unknown
• Conditions: Alveolar Bone Loss; Alveolar Ridge Pathology | Gingiva | Dental
• Intervention / Treatment: Device: gene-activated bone substitute mixed with autobone

Detailed Description

An open-label randomized controlled clinical trial, two cohort. Patients who met the inclusion criteria is planned to be enrolled into the trial. On enrollment, all patients will have screening, a set of clinical examination, instrumental investigations and laboratory tests, including dental CT of the affected jaw with the assessment of alveolar ridge width and height.

All patients enrolled in the study will be subjected to guided bone regeneration surgery of the upper or lower jaw with the use of investigational bone substitutes mixed with shredded autobone harvested during the surgery. If the height of alveolar ridge needs to be augmented, the non-resorbed systems for granular material fixation will be used.

The clinical study results will be evaluated at the time points of 1, 2, 10, 30, 90, and 180 days with clinical examination, instrumental investigations and laboratory tests. A control dental CT will be carried out before dental implantation for the primary outcome measure, at 180 days after surgery. The clinical trial completion date is the day of the second surgery, a dental implant placement. During the procedure, trephine biopsy samples will be harvested from the bone grafting area addressing the secondary outcome measure.

• Study Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127473
    • A.I. Evdokimov Moscow State University of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are subjected to guided bone regeneration surgery of the upper or lower jaw for subsequent dental implants placement.

Description

Inclusion Criteria:

• partial or full edentulism;
• alveolar ridge atrophy and defects preventing from dental implant placement;
• obtained voluntary informed consent for participation in the clinical study

Exclusion Criteria:

• disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial;
• plaque index (PI) score > 15%;
• gingival sulcus bleeding index (SBI) > 10%
• decompensated chronic diseases;
• alcohol addiction;
• a history of drug addiction;
• a history of medication with drugs affecting bone tissue metabolism;
• participation in other clinical trials (or the administration of investigational products) within 3 months prior to the study;
• conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism);
• pregnancy or lactation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
test group; bone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone	Device: gene-activated bone substitute mixed with autobone; gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone; Other Names: xenogenic deproteinized bone matrix mixed with autobone
control group; bone grafting with xenogenic deproteinized bone matrix mixed with autobone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of soft tissues (fat and fibrous) with density less then 120 HU within total volume of tissues in the bone grafting area by CT scan	Evaluation of the total volume of tissues in the bone grafting area using manual segmentation tool and subsequent calculation of a proportion of the low-density tissues	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events and Serious Adverse Events	evaluation of the Adverse Events and Serious Adverse Events frequency	6 months
post-operative pain level	level of local pain assessed by Numeric rating scale (1-10)	6 months
post-operative swelling level	post-operative swelling level assessed by Numeric rating scale	6 months
newly formed bone tissue level	Volume of newly formed bone tissue in the trephine biopsy samples measured as a percentage of bone tissue in total square of histological slice	6 months

Collaborators and Investigators

• Sponsor: Histograft Co., Ltd.
• Collaborators: Moscow State University of Medicine and Dentistry
• Investigators: Principal Investigator: Grigory Volozhin, MD, PhD, A.I. Evdokimov Moscow State University of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: dental implants; bone grafting; alveolar ridge atrophy; gene-activated matrix
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: RU-GAM-20-05-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No