Alveolar Bone Loss, Alveolar Ridge Pathology | Gingiva | Dental
Conditions
Keywords
alveolar ridge atrophy, bone grafting, gene-activated matrix, dental implants
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.
Interventions
DEVICEgene-activated bone substitute mixed with autobone
gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
Sponsors
Moscow State University of Medicine and Dentistry
Histograft Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events and Serious Adverse Events | 6 months | evaluation of the Adverse Events and Serious Adverse Events frequency |
| post-operative pain level | 6 months | level of local pain assessed by Numeric rating scale (1-10) |
| post-operative swelling level | 6 months | post-operative swelling level assessed by Numeric rating scale |
| newly formed bone tissue level | 6 months | Volume of newly formed bone tissue in the trephine biopsy samples measured as a percentage of bone tissue in total square of histological slice |
Countries
Russia
Outcome results
None listed