Vibropneumostimulation in the Rehabilitation After Dental Implantation

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implantation
• Intervention / Treatment: Device: Vibropneumostimulation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ivan Bayrikov, MD; Phone Number: +79061274992; Email: i.m.bajrikov@samsmu.ru
• Study Contact Backup: Name: Olga Dragunkina; Phone Number: +79372341724; Email: dantex2010@rambler.ru

Study Locations

• Russian Federation
  • Samara, Russian Federation
    • Recruiting
    • Samara State Medical University
    • Contact: Ivan Bayrikov, MD; Phone Number: +79061274992; Email: i.m.bajrikov@samsmu.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
installation of the gumformer	rate of patients with installation of the gumformer on the installed implants according to the X-ray	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	7 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: dental implantation; vibropneumostimulation
• Other Study ID Numbers: 190

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No