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CompletedNCT03415971Updated Jan 30, 2018

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

An interventional study of EMG befor denture treatment and EMG in a month after termination of treatment in Edentulous, Teeth Replacement and Bounded Edentulous Space, sponsored by North-Western State Medical University named after I.I.Mechnikov. Completed. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by North-Western State Medical University named after I.I.Mechnikov · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Edentulous
  • Teeth Replacement
  • Bounded Edentulous Space

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03

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Partially edentulous bounded space in dental arch (not more that 3 teeth absent)
  • Patients ages 20-45 y.o.

Exclusion criteria

Exclusion Criteria:

  • Chronical third-degree cardiac failure
  • Connective tissue diseases
  • Decompensated diabetes
  • Neoplastic processes
  • Strokes
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Active comparator
    ASTRA TECH implants

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

    Procedure: EMG befor denture treatment · Procedure: EMG in a month after termination of treatment · Procedure: EMG in a 3 months after termination of treatment

  • Active comparator
    CROWN

    to fixed denture restorations in own teeth - 32 patients

    Procedure: EMG befor denture treatment · Procedure: EMG in a month after termination of treatment · Procedure: EMG in a 3 months after termination of treatment

  • Placebo comparator
    non-edontulos

    control group will consist 38 non-edotulos patients

    Procedure: EMG befor denture treatment

Interventions

  • ProcedureEMG befor denture treatment

    Also known as: electromyographia

  • ProcedureEMG in a month after termination of treatment

    Also known as: electromyographia

  • ProcedureEMG in a 3 months after termination of treatment

    Also known as: electromyographia

05

What researchers measure

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.

    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.

    Time frame: up to 3 months.

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03415971
Lead sponsor
North-Western State Medical University named after I.I.Mechnikov
Responsible party
Silin Alexey Viktorovich (Principal Investigator, North-Western State Medical University named after I.I.Mechnikov) — Principal investigator
First posted
Jan 30, 2018
Start date
Oct 2015
Primary completion
Jan 2016
Completion
Jan 23, 2018
Last update
Jan 30, 2018
View the source record on ClinicalTrials.gov ↗

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