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

Not Applicable

Completed

• Conditions: Teeth Replacement; Bounded Edentulous Space; Edentulous
• Interventions: Procedure: EMG befor denture treatment; Procedure: EMG in a month after termination of treatment; Procedure: EMG in a 3 months after termination of treatment

• Registration Number: NCT03415971
• Lead Sponsor: North-Western State Medical University named after I.I.Mechnikov

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.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-01
• Study First Submitted: 2016-01-28
• Status Verified: 2018-01
• Study Completion: 2018-01-23
• Study First Submitted QC: 2018-01-23
• Last Update Submitted: 2018-01-23
• Study First Posted: 2018-01-30
• Last Update Posted: 2018-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASTRA TECH implants	EMG in a 3 months after termination of treatment	implant restoration(replace of a missing tooth) - 35 patients
ASTRA TECH implants	EMG befor denture treatment	implant restoration(replace of a missing tooth) - 35 patients
ASTRA TECH implants	EMG in a month after termination of treatment	implant restoration(replace of a missing tooth) - 35 patients
non-edontulos	EMG befor denture treatment	control group will consist 38 non-edotulos patients
CROWN	EMG befor denture treatment	to fixed denture restorations in own teeth - 32 patients
CROWN	EMG in a month after termination of treatment	to fixed denture restorations in own teeth - 32 patients
CROWN	EMG in a 3 months after termination of treatment	to fixed denture restorations in own teeth - 32 patients

Primary Outcome Measures

Name	Time	Method
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.	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.