Status:
UNKNOWN
Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation
Lead Sponsor:
Histograft Co., Ltd.
Collaborating Sponsors:
Moscow State University of Medicine and Dentistry
Conditions:
Alveolar Bone Loss
Alveolar Ridge Pathology | Gingiva | Dental
Eligibility:
All Genders
18-70 years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04511689
Start Date
July 1 2020
End Date
August 1 2021
Last Update
August 13 2020
Active Locations (1)
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1
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Moscow, Russia, 127473