Alveolar Bone LossNCT04511689
Comparative Study of Gene-activated Bone Substitute and Xenogenic Bone Matrix in Alveolar Ridge Augmentation
An observational study of Alveolar Bone Loss and Alveolar Ridge Pathology | Gingiva | Dental, run by Histograft Co., Ltd. at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alveolar Bone Loss, Alveolar Ridge Pathology | Gingiva | Dental
- What is being tested?
- gene-activated bone substitute mixed with autobone
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2020to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are subjected to guided bone regeneration surgery of the upper or lower jaw for subsequent dental implants placement.
Who may be able to join
- partial or full edentulism;
- alveolar ridge atrophy and defects preventing from dental implant placement;
- obtained voluntary informed consent for participation in the clinical study
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
Russia1 site
A.I. Evdokimov Moscow State University of Medicine and Dentistry
Moscow, 127473
About this study
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
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
Read the 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.
- Being tested
- gene-activated bone substitute mixed with autobone
- Keywords
- alveolar ridge atrophy, bone grafting, gene-activated matrix, dental implants
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene-activated bone substitute mixed with autoboneDevice
Also called xenogenic deproteinized bone matrix mixed with autobone
gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
| Study group | Role | What they receive |
|---|---|---|
| test group | bone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone Receives: Device: gene-activated bone substitute mixed with autobone | |
| control group | bone grafting with xenogenic deproteinized bone matrix mixed with autobone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Adverse Events and Serious Adverse Events
evaluation of the Adverse Events and Serious Adverse Events frequency
Measured: 6 months
post-operative pain level
level of local pain assessed by Numeric rating scale (1-10)
Measured: 6 months
post-operative swelling level
post-operative swelling level assessed by Numeric rating scale
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Histograft Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry
- Responsible party
- Sponsor
- Investigators
- Grigory Volozhin, MD, PhD, Principal investigator, A.I. Evdokimov Moscow State University of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511689
- Sponsor's protocol ID
- RU-GAM-20-05-2020
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04511689
- Acronym / sponsor ID
- RU-GAM-20-05-2020
- Keywords
- alveolar ridge atrophy, bone grafting, gene-activated matrix, dental implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Histograft Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Moscow State University of Medicine and Dentistry
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | – | Device: gene-activated bone substitute mixed with autobonebone grafting with gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone |
| control group | – | –bone grafting with xenogenic deproteinized bone matrix mixed with autobone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are subjected to guided bone regeneration surgery of the upper or lower jaw for subsequent dental implants placement.
Key inclusion criteria (3 listed)
- partial or full edentulism;
- alveolar ridge atrophy and defects preventing from dental implant placement;
- obtained voluntary informed consent for participation in the clinical study
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gene-activated bone substitute mixed with autoboneAlso: xenogenic deproteinized bone matrix mixed with autobonegene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone | Device | test group |
Primary outcome
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
4 secondary outcomes
Adverse Events and Serious Adverse Events
Time frame: 6 months
post-operative pain level
Time frame: 6 months
post-operative swelling level
Time frame: 6 months
newly formed bone tissue level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grigory Volozhin, MD, PhD principal investigator
A.I. Evdokimov Moscow State University of Medicine and Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alveolar Bone Loss and Alveolar Ridge Pathology | Gingiva | Dental, run by Histograft Co., Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.