Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation
1 other identifier
observational
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 11, 2020
CompletedFirst Posted
Study publicly available on registry
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedAugust 13, 2020
August 1, 2020
1 year
August 11, 2020
August 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Adverse Events and Serious Adverse Events
6 months
post-operative pain level
6 months
post-operative swelling level
6 months
newly formed bone tissue level
6 months
Study Arms (2)
test group
bone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
control group
bone grafting with xenogenic deproteinized bone matrix mixed with autobone
Interventions
gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
Eligibility Criteria
Patients who are subjected to guided bone regeneration surgery of the upper or lower jaw for subsequent dental implants placement.
You may qualify if:
- partial or full edentulism;
- alveolar ridge atrophy and defects preventing from dental implant placement;
- obtained voluntary informed consent for participation in the clinical study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Moscow, 127473, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grigory Volozhin, MD, PhD
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2020
First Posted
August 13, 2020
Study Start
July 1, 2020
Primary Completion
July 1, 2021
Study Completion
August 1, 2021
Last Updated
August 13, 2020
Record last verified: 2020-08