Vibropneumostimulation in the Rehabilitation After Dental Implantation

Dental Implantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758337
• Other study ID #: 190
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Samara State Medical University
• Contact: Ivan Bayrikov, MD
• Phone: +79061274992
• Email: i.m.bajrikov[@]samsmu.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 -

Related Conditions & MeSH terms

• Dental Implantation

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Samara state medical university	Samara

Sponsors (1)

Lead Sponsor	Collaborator
Samara State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	installation of the gumformer	rate of patients with installation of the gumformer on the installed implants according to the X-ray	7 months
Secondary	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