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

NCT ID: NCT03415971

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-01-23

Brief Summary

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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

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

Conditions

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Edentulous Teeth Replacement Bounded Edentulous Space

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASTRA TECH implants

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

Group Type ACTIVE_COMPARATOR

EMG befor denture treatment

Intervention Type PROCEDURE

EMG in a month after termination of treatment

Intervention Type PROCEDURE

EMG in a 3 months after termination of treatment

Intervention Type PROCEDURE

CROWN

to fixed denture restorations in own teeth - 32 patients

Group Type ACTIVE_COMPARATOR

EMG befor denture treatment

Intervention Type PROCEDURE

EMG in a month after termination of treatment

Intervention Type PROCEDURE

EMG in a 3 months after termination of treatment

Intervention Type PROCEDURE

non-edontulos

control group will consist 38 non-edotulos patients

Group Type PLACEBO_COMPARATOR

EMG befor denture treatment

Intervention Type PROCEDURE

Interventions

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EMG befor denture treatment

Intervention Type PROCEDURE

EMG in a month after termination of treatment

Intervention Type PROCEDURE

EMG in a 3 months after termination of treatment

Intervention Type PROCEDURE

Other Intervention Names

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electromyographia electromyographia electromyographia

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Silin Alexey Viktorovich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NWSMU

Identifier Type: -

Identifier Source: org_study_id

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