Vibropneumostimulation in the Rehabilitation After Dental Implantation

Not Applicable

Recruiting

• Conditions: Dental Implantation
• Interventions: Device: Vibropneumostimulation

• Registration Number: NCT05758337
• Lead Sponsor: Samara State Medical University

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.

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 Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-05
• Study First Posted: 2023-03-07
• Status Verified: 2024-09
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A group with exposure of vibropneumostimulation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
installation of the gumformer	7 months	rate of patients with installation of the gumformer on the installed implants according to the X-ray
the beginning of the functional load	7 months	rate of patients with the beginning of the functional load on the restored dentition according to the X-ray

Trial Locations

Locations (1)

Samara state medical university; 🇷🇺 Samara, Russian Federation