Dental ImplantationNCT05758337
Vibropneumostimulation in the Rehabilitation After Dental Implantation
A study testing Vibropneumostimulation in people with Dental Implantation, run by Samara State Medical University at 1 site in Russia.
Trial summary
A new comprehensive technique of dental implantation and rehabilitation of patients will be developed and theoretically justified, including an individual dental implant of a dowel system made of non-woven titanium material with through porosity and vibropneumostimulation, which will improve the functional and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Vibropneumostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with a history of previous unsuccessful implantations,
- patients with a history of bad habits,
- patients with low bone density (CT),
- patients who have sinus lifting surgery performed simultaneously
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Functional Rationalization of the Use of Vibropneumostimulation in the Rehabilitation System of Patients After Dental Implantation
A new comprehensive technique of dental implantation and rehabilitation of patients will be developed and theoretically justified, including an individual dental implant of a dowel system made of non-woven titanium material with through porosity and vibropneumostimulation, which will improve the functional and anatomical results of treatment.
In the complex treatment and rehabilitation of patients after dental implantation, a vibropneumostimulator with vibratodes of its own design will be used, which activate bone remodeling, which will expand the practical application and theoretical knowledge in the field of hardware massage.
Read the detailed description
The aim of the study: to improve the results of treatment of patients after dental implantation by using vibropneumostimulation of periimplant tissues.
In the work, a complex of functional and clinical methods (thermography, radiography, periotestometry) will be used. The following methods will also be used:
- echosteometry, thanks to which the density of bone tissue in the periimplant zone will be studied, which will allow to study the processes of bone tissue remodulation.
- radioisotope diagnostics, thanks to which the dynamics of bone metabolism processes around implants will be studied, which will expand the knowledge of the metabolism of jaw bones.
The subject of the study is the remodulation of bone tissue around the implant, which will allow us to develop a new concept of the relationship of processes in the bone tissue around implants of various designs. The study is based on the study and generalization of existing scientific data on surgical treatment of patients, as well as on the assessment of the relevance and degree of development of the topic. To improve the quality of care for patients after implantation, in our research we will use vibro-pneumatic action on the tissues of the upper and lower jaws in the field of implantation by a device of the SamSMU design - a medical vibro-pneumatic stimulator, it will be an automated system for pneumatic wave massage and vibration exposure.
A vibropneumostimulator with vibratodes of its own design will be introduced into clinical practice, which will expand the arsenal of hardware treatment of an implantologist.
In the complex treatment of patients with partial and complete loss of teeth, an improved dental implant of a dowel system made of non-woven titanium material with through porosity will be offered for using.
- Conditions
- Dental Implantation
- Being tested
- Vibropneumostimulation
- Keywords
- dental implantation, vibropneumostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibropneumostimulationDevice
New vibrators and techniques of vibropneumostimulation of periimplant tissues have been developed, which will allow us to develop a new concept of the relationship of bone remodulation processes around implants of various designs.
| Study group | Role | What they receive |
|---|---|---|
| A group with exposure of vibropneumostimulation | Experimental | The first group is a group of subjects on whom, after implantation, a new technique was applied, including the effect of vibropneumostimulation on the pereimplant tissues. Receives: Device: Vibropneumostimulation |
| A group of standart therapy | No intervention | The second is a group of subjects whose rehabilitation was carried out by the well-known classical method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
restoration of dentition by installing crowns on the installed implants
implant stability according to the method of Resonance Frequency Analysis that register magnetic vibrations of the pin together with the implant in the form of an indicator Implant Stability Quotient
Measured: 4 months
Secondary outcomes (2)
installation of the gumformer
rate of patients with installation of the gumformer on the installed implants according to the X-ray
Measured: 7 months
the beginning of the functional load
rate of patients with the beginning of the functional load on the restored dentition according to the X-ray
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start1 Sep 2022
- Primary completion30 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The first group is a group of subjects on whom, after implantation, a new technique was applied, including the effect of vibropneumostimulation on the pereimplant tissues
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivan Bayrikov, MD, Study director, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758337
- Sponsor's protocol ID
- 190
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Functional Rationalization of the Use of Vibropneumostimulation in the Rehabilitation System of Patients After Dental Implantation
- ClinicalTrials.gov ID
- NCT05758337
- Acronym / sponsor ID
- 190
- Conditions
- Dental Implantation
- Keywords
- dental implantation, vibropneumostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 7 Mar 2023 (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.
A new comprehensive technique of dental implantation and rehabilitation of patients will be developed and theoretically justified, including an individual dental implant of a dowel system made of non-woven titanium material with through porosity and vibropneumostimulation, which will improve the functional and anatomical results of treatment.
In the complex treatment and rehabilitation of patients after dental implantation, a vibropneumostimulator with vibratodes of its own design will be used, which activate bone remodeling, which will expand the practical application and theoretical knowledge in the field of hardware massage.
Detailed description
The aim of the study: to improve the results of treatment of patients after dental implantation by using vibropneumostimulation of periimplant tissues.
In the work, a complex of functional and clinical methods (thermography, radiography, periotestometry) will be used. The following methods will also be used:
- echosteometry, thanks to which the density of bone tissue in the periimplant zone will be studied, which will allow to study the processes of bone tissue remodulation.
- radioisotope diagnostics, thanks to which the dynamics of bone metabolism processes around implants will be studied, which will expand the knowledge of the metabolism of jaw bones.
The subject of the study is the remodulation of bone tissue around the implant, which will allow us to develop a new concept of the relationship of processes in the bone tissue around implants of various designs. The study is based on the study and generalization of existing scientific data on surgical treatment of patients, as well as on the assessment of the relevance and degree of development of the topic. To improve the quality of care for patients after implantation, in our research we will use vibro-pneumatic action on the tissues of the upper and lower jaws in the field of implantation by a device of the SamSMU design - a medical vibro-pneumatic stimulator, it will be an automated system for pneumatic wave massage and vibration exposure.
A vibropneumostimulator with vibratodes of its own design will be introduced into clinical practice, which will expand the arsenal of hardware treatment of an implantologist.
In the complex treatment of patients with partial and complete loss of teeth, an improved dental implant of a dowel system made of non-woven titanium material with through porosity will be offered for using.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The first group is a group of subjects on whom, after implantation, a new technique was applied, including the effect of vibropneumostimulation on the pereimplant tissues
| Arm | Type | Receives |
|---|---|---|
| A group with exposure of vibropneumostimulation | Experimental | Device: VibropneumostimulationThe first group is a group of subjects on whom, after implantation, a new technique was applied, including the effect of vibropneumostimulation on the pereimplant tissues. |
| A group of standart therapy | No intervention | –The second is a group of subjects whose rehabilitation was carried out by the well-known classical method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients with a history of previous unsuccessful implantations,
- patients with a history of bad habits,
- patients with low bone density (CT),
- patients who have sinus lifting surgery performed simultaneously
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| VibropneumostimulationNew vibrators and techniques of vibropneumostimulation of periimplant tissues have been developed, which will allow us to develop a new concept of the relationship of bone remodulation processes around implants of various designs. | Device | A group with exposure of vibropneumostimulation |
Primary outcome
restoration of dentition by installing crowns on the installed implants
Time frame: 4 months
implant stability according to the method of Resonance Frequency Analysis that register magnetic vibrations of the pin together with the implant in the form of an indicator Implant Stability Quotient
2 secondary outcomes
installation of the gumformer
Time frame: 7 months
the beginning of the functional load
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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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.
Ivan Bayrikov, MD study director
Samara State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibropneumostimulation in people with Dental Implantation, run by Samara State Medical University 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 16 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
restoration of dentition by installing crowns on the installed implants (time frame: 4 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 16 Oct 2026.