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Clinical Trials/NCT05493579
NCT05493579CompletedNot Applicable

"Impact of Mandibular Implant Supported Overdenture on Changes of Electromyographic Activity, Brain Activity, Cognitive Function, Nutrition and Depression Status."

Al-Azhar University1 site in 1 country10 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Brain Activity (EEG)

Study Overview

Brief Summary

The purpose of this study is to evaluate and compare the effects of a mandibular implant-supported overdenture with a mandibular complete denture on electromyographic activity, brain activity, and cognitive performance in edentulous patients. Ten patients who are entirely edentulous and did not wear dentures will be chosen. To assess brain activity and cognitive function, electroencephalograms, the Mini-Mental State Examination (MMSE), and electromyographic examinations of the temporalis and masseter muscles will be performed prior to complete denture construction, one and three months after complete denture construction, and one and three months after implant supported overdenture insertion, respectively.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to 69 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
  • •Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
  • •All patients must have sufficient inter arch space.

Exclusion Criteria

  • •Patients with oral or systemic diseases.
  • •Patients with xerostomia or excessive salivation.
  • •Patients with parafunctional habits (bruxism or clenching).
  • •Heavy smoker or alcoholic patients.
  • •Patients with history of temporo-mandibular dysfunction.
  • •Patients with neurological or psychiatric disorders.

Arms & Interventions

Complete denture then complete implant supported overdenture

Experimental

Intervention: Implant supported overdenture (Other)

Outcomes

Primary Outcomes

Brain Activity (EEG)

Time Frame: 3 months

An assessment of the patient's brain activity will be done. The waves obtained during all phases of assessment will be analyzed, and the software will separate the alpha waves, which occur in the frequency range of 8-12 Hz, evaluating their amplitude. The mean amplitude (in microvolts) of alpha waves was obtained.

Secondary Outcomes

  • Cognitive Function (MMSE)(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Noha Taha Kamel Taha Alloush

Assistant Lecturer

Misr International University

Study Sites (1)

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