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

Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415971
• Other study ID #: NWSMU
• Status: Completed
• Phase: N/A
• First received: January 28, 2016
• Last updated: January 23, 2018
• Start date: October 2015
• Est. completion date: January 23, 2018

Study information

• Verified date: January 2018
• Source: North-Western State Medical University named after I.I.Mechnikov
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 23, 2018
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bounded Edentulous Space
• Edentulous
• Mouth, Edentulous
• Teeth Replacement

Intervention

Procedure:
• EMG befor denture treatment

• EMG in a month after termination of treatment

• EMG in a 3 months after termination of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North-Western State Medical University named after I.I.Mechnikov

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.