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Trial record 3 of 3 for:    histograft

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511689
Recruitment Status : Unknown
Verified August 2020 by Histograft Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Moscow State University of Medicine and Dentistry
Information provided by (Responsible Party):
Histograft Co., Ltd.

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

Condition or disease Intervention/treatment
Alveolar Bone Loss Alveolar Ridge Pathology | Gingiva | Dental Device: gene-activated bone substitute mixed with autobone

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
test group
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
gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
Other Name: xenogenic deproteinized bone matrix mixed with autobone

control group
bone grafting with xenogenic deproteinized bone matrix mixed with autobone



Primary Outcome Measures :
  1. 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 [ Time Frame: 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 Outcome Measures :
  1. Adverse Events and Serious Adverse Events [ Time Frame: 6 months ]
    evaluation of the Adverse Events and Serious Adverse Events frequency

  2. post-operative pain level [ Time Frame: 6 months ]
    level of local pain assessed by Numeric rating scale (1-10)

  3. post-operative swelling level [ Time Frame: 6 months ]
    post-operative swelling level assessed by Numeric rating scale

  4. newly formed bone tissue level [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511689


Locations
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Russian Federation
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Moscow, Russian Federation, 127473
Sponsors and Collaborators
Histograft Co., Ltd.
Moscow State University of Medicine and Dentistry
Investigators
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Principal Investigator: Grigory Volozhin, MD, PhD A.I. Evdokimov Moscow State University of Medicine and Dentistry
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Responsible Party: Histograft Co., Ltd.
ClinicalTrials.gov Identifier: NCT04511689    
Other Study ID Numbers: RU-GAM-20-05-2020
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Histograft Co., Ltd.:
alveolar ridge atrophy
bone grafting
gene-activated matrix
dental implants
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases