Vibropneumostimulation in the Rehabilitation After Dental Implantation

Sponsor
Samara State Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05758337
Collaborator
(none)
100
1
2
24
4.2

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Vibropneumostimulation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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 tissuesThe 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 (Participant)
Masking Description:
The second is a group of subjects whose rehabilitation was carried out by the well-known classical method
Primary Purpose:
Treatment
Official Title:
Clinical and Functional Rationalization of the Use of Vibropneumostimulation in the Rehabilitation System of Patients After Dental Implantation
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: A group with exposure of vibropneumostimulation

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.

Device: Vibropneumostimulation
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.

No Intervention: A group of standart therapy

The second is a group of subjects whose rehabilitation was carried out by the well-known classical method.

Outcome Measures

Primary Outcome Measures

  1. restoration of dentition by installing crowns on the installed implants [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

Secondary Outcome Measures

  1. installation of the gumformer [7 months]

    installation of the gumformer on the installed implants according to the X-ray

  2. the beginning of the functional load [7 months]

    the beginning of the functional load on the restored dentition according to the X-ray

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria: No

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Contacts and Locations

Locations

Site City State Country Postal Code
1 Samara state medical university Samara Russian Federation

Sponsors and Collaborators

  • Samara State Medical University

Investigators

  • Study Director: Ivan Bayrikov, MD, Samara State Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samara State Medical University
ClinicalTrials.gov Identifier:
NCT05758337
Other Study ID Numbers:
  • 190
First Posted:
Mar 7, 2023
Last Update Posted:
Mar 7, 2023
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samara State Medical University

Study Results

No Results Posted as of Mar 7, 2023