Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)

January 23, 2018 updated by: Silin Alexey Viktorovich, North-Western State Medical University named after I.I.Mechnikov
The result of the study will demonstrate that the functional activity of maxillofacial area with edentulous posterior bounded spaces recovers more effectively in patients treated with restorations on implants comparing to patients treated with fixed dentures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All patients will be provided with electromyographic research before denture treatment, in a month and three months after the termination of treatment.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
  • Patients ages 20-45 y.o.

Exclusion Criteria:

  • Chronical third-degree cardiac failure
  • Connective tissue diseases
  • Decompensated diabetes
  • Neoplastic processes
  • Strokes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ASTRA TECH implants
implant restoration(replace of a missing tooth) - 35 patients
Procedure: EMG befor denture treatment
Other Names:
  • electromyographia
Procedure: EMG in a month after termination of treatment
Other Names:
  • electromyographia
Procedure: EMG in a 3 months after termination of treatment
Other Names:
  • electromyographia
Active Comparator: CROWN
to fixed denture restorations in own teeth - 32 patients
Procedure: EMG befor denture treatment
Other Names:
  • electromyographia
Procedure: EMG in a month after termination of treatment
Other Names:
  • electromyographia
Procedure: EMG in a 3 months after termination of treatment
Other Names:
  • electromyographia
Placebo Comparator: non-edontulos
control group will consist 38 non-edotulos patients
Procedure: EMG befor denture treatment
Other Names:
  • electromyographia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The signals were averaged over 25 ms, with muscle activity assessed as the root mean square (RMS) of the amplitude (µV). sEMG signals were recorded for further analysis.
Time Frame: up to 3 months.
The present study demonstrated that Osseo Speed implants are safe and reasonable way of treatment for partial tooth loss in the lateral side. There was observed healthy soft tissue and marginal bone stability around the implants. Received data analysis using surface EMG allow to assume than functional state of maxillofacial region and neuromuscular coordination of the muscles of mastication in patients with bounded edentulous space in the lateral side (molars and/or premolars) with implant-supported prosthesis is considerably better than in patients with fixed bridges. Implant-supported prosthesis provide greater bite force for chewing function in comparison with fixed bridges , but certainly less effective than natural teeth. Implant-supported prosthesis increase patients' quality of life and is more convenient for dentoalveolar apparatus.
up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North-Western State Medical University named after I.I.Mechnikov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 23, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

January 23, 2018

First Posted (Actual)

January 30, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NWSMU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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