Clinical trial NCT04511689: Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alveolar Bone Loss
Alveolar Ridge Pathology &#X7C; Gingiva &#X7C; Dental
Keywords: alveolar ridge atrophy
bone grafting
gene-activated matrix
dental implants
Lead sponsor: Histograft Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Moscow State University of Medicine and Dentistry
First posted: 2020-08-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events and Serious Adverse Events
timeFrame: 6 months
measure: post-operative pain level
timeFrame: 6 months
measure: post-operative swelling level
timeFrame: 6 months
measure: newly formed bone tissue level
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: A.I. Evdokimov Moscow State University of Medicine and Dentistry
Study officials:
affiliation: A.I. Evdokimov Moscow State University of Medicine and Dentistry
name: Grigory Volozhin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: