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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Alveolar Bone Loss, Alveolar Ridge Pathology &#X7C; Gingiva &#X7C; Dental

Intervention / Treatment
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* Device: gene-activated bone substitute mixed with autobone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| test group<br>bone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone | Device: gene-activated bone substitute mixed with autobone<br>* gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone<br>* Other names: xenogenic deproteinized bone matrix mixed with autobone;|
| control group<br>bone grafting with xenogenic deproteinized bone matrix mixed with autobone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events and Serious Adverse Events | evaluation of the Adverse Events and Serious Adverse Events frequency | 6 months | 
| post-operative pain level | level of local pain assessed by Numeric rating scale (1-10) | 6 months | 
| post-operative swelling level | post-operative swelling level assessed by Numeric rating scale | 6 months | 
| newly formed bone tissue level | Volume of newly formed bone tissue in the trephine biopsy samples measured as a percentage of bone tissue in total square of histological slice | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alveolar ridge atrophy, bone grafting, gene-activated matrix, dental implants