Vibropneumostimulation in the Rehabilitation After Dental Implantation

NCT05758337 | Recruiting DMC

• 1 other identifier: 190
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implantation

Keywords

dental implantation; vibropneumostimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• installation of the gumformer

  7 months

• the beginning of the functional load

  7 months

Study Arms (2)

A group with exposure of vibropneumostimulation

EXPERIMENTAL

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

A group of standart therapy

NO INTERVENTION

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

Interventions

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.

A group with exposure of vibropneumostimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Samara State Medical University: lead

Study Sites (1)

Samara state medical university

Samara, Russia

RECRUITING

Study Officials

• Ivan Bayrikov, MD

  Samara State Medical University

  STUDY DIRECTOR

Central Study Contacts

Ivan Bayrikov, MD

CONTACT

+79061274992; i.m.bajrikov@samsmu.ru

Olga Dragunkina

CONTACT

+79372341724; dantex2010@rambler.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The second is a group of subjects whose rehabilitation was carried out by the well-known classical method
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 7, 2023
• Study Start: September 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: September 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-09

Locations

RU (1)