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

Primary Purpose

Edentulous, Teeth Replacement, Bounded Edentulous Space

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMG befor denture treatment
EMG in a month after termination of treatment
EMG in a 3 months after termination of treatment
Sponsored by
North-Western State Medical University named after I.I.Mechnikov
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    ASTRA TECH implants

    CROWN

    non-edontulos

    Arm Description

    implant restoration(replace of a missing tooth) - 35 patients

    to fixed denture restorations in own teeth - 32 patients

    control group will consist 38 non-edotulos patients

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2016
    Last Updated
    January 23, 2018
    Sponsor
    North-Western State Medical University named after I.I.Mechnikov
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03415971
    Brief Title
    Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
    Official Title
    Electromyographic Estimation of Neuro-muscular Coordination of Masticatory Muscles in Patients Treated With Implants (D-2012-057)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 23, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    North-Western State Medical University named after I.I.Mechnikov

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous, Teeth Replacement, Bounded Edentulous Space

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ASTRA TECH implants
    Arm Type
    Active Comparator
    Arm Description
    implant restoration(replace of a missing tooth) - 35 patients
    Arm Title
    CROWN
    Arm Type
    Active Comparator
    Arm Description
    to fixed denture restorations in own teeth - 32 patients
    Arm Title
    non-edontulos
    Arm Type
    Placebo Comparator
    Arm Description
    control group will consist 38 non-edotulos patients
    Intervention Type
    Procedure
    Intervention Name(s)
    EMG befor denture treatment
    Other Intervention Name(s)
    electromyographia
    Intervention Type
    Procedure
    Intervention Name(s)
    EMG in a month after termination of treatment
    Other Intervention Name(s)
    electromyographia
    Intervention Type
    Procedure
    Intervention Name(s)
    EMG in a 3 months after termination of treatment
    Other Intervention Name(s)
    electromyographia
    Primary Outcome Measure Information:
    Title
    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.
    Description
    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.
    Time Frame
    up to 3 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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