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

Study Overview
=================
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.

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

Conditions
-----------------
Bounded Edentulous Space, Edentulous, Teeth Replacement

Intervention / Treatment
-----------------
* Procedure: EMG befor denture treatment
* Procedure: EMG in a month after termination of treatment
* Procedure: EMG in a 3 months after termination of treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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