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Completed

NCT Number: NCT03415971

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

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.

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Key information

Conditions

Edentulous Bounded Edentulous Space Mouth Diseases Mouth, Edentulous Stomatognathic Diseases Teeth Replacement Tooth Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMG befor denture treatment

Procedure

Other names: electromyographia

EMG in a month after termination of treatment

Procedure

Other names: electromyographia

EMG in a 3 months after termination of treatment

Procedure

Other names: electromyographia

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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