Actively Recruiting

Phase Not Applicable
All Genders
ID05758337

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

Led by Samara State Medical University · Updated on 2024-12-13

100

Participants Needed

1

Research Sites

9 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring a new method to improve treatment and rehabilitation after dental implantation. This method includes using an individual dental implant made of non-woven titanium with through porosity and a special vibropneumostimulation device designed to activate bone remodeling. The study aims to enhance the functional and anatomical outcomes of dental implant treatments by applying this innovative approach. Participants in the study will be divided into two groups. One group will receive the new technique, which involves vibropneumostimulation applied to the tissues around the dental implant. The other group will undergo the standard rehabilitation method. The vibropneumostimulation device uses pneumatic wave massage and vibration to stimulate bone tissue remodeling. Additionally, a dowel system dental implant made from non-woven titanium material will be used in the complex treatment of patients with partial or complete tooth loss. During the study, participants will be assessed through various methods including thermography, radiography, periotestometry, echosteometry to measure bone density around the implant, and radioisotope diagnostics to monitor bone metabolism. The primary outcome is the restoration of dentition by installing crowns on the implants within 4 months. Secondary outcomes include installation of the gumformer and the start of functional load at 7 months. The total observation period and detailed follow-up ensure thorough evaluation of the treatment effects and safety.

CONDITIONS

Brief Title

Vibropneumostimulation in the Rehabilitation After Dental Implantation

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a history of previous unsuccessful dental implantations
  • Patients with a history of bad habits
  • Patients with low bone density confirmed by CT
  • Patients who have had sinus lifting surgery performed simultaneously with implantation
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 7 months

Participants receive either vibropneumostimulation using a medical vibro-pneumatic stimulator or standard therapy after dental implantation to support rehabilitation and bone tissue remodulation around implants.

Multiple visits during treatment period depending on therapy type

Follow-up

Duration - Up to 4 months after treatment

Participants will be monitored for restoration of dentition by installing crowns on implants and other functional outcomes after treatment.

Follow-up visits as scheduled for assessment of implant function

Trial Site Locations

Total: 1 location

1

Samara state medical university

Samara, Russia

Actively Recruiting

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Research Team

I

Ivan Bayrikov, MD

O

Olga Dragunkina

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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