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

Histograft

Status: Unknown

Conditions: Alveolar Ridge Pathology | Gingiva | Dental; Alveolar Bone Loss

Treatments: Device: gene-activated bone substitute mixed with autobone

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04511689

RU-GAM-20-05-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

test group

Description:

bone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone

Treatment:

Device: gene-activated bone substitute mixed with autobone

control group

Description:

bone grafting with xenogenic deproteinized bone matrix mixed with autobone