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NCT Number: NCT05758337

Vibropneumostimulation in the Rehabilitation 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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara state medical university

Samara, Russia

Location status: Recruiting

Location contact

Ivan Bayrikov, MD

CONTACT

[email protected]

+79061274992

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Vibropneumostimulation

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. installation of the gumformer

    Time frame: 7 months

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

  2. the beginning of the functional load

    Time frame: 7 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ivan Bayrikov, MD

CONTACT

[email protected]

+79061274992

Olga Dragunkina

CONTACT

[email protected]

+79372341724

Sponsors and collaborators

Lead sponsor

Samara State Medical University

Other

Registry information

Official study title

Clinical and Functional Rationalization of the Use of Vibropneumostimulation in the Rehabilitation System of Patients After Dental Implantation

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2023
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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