Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain Activity

Sponsor
Al-Azhar University (Other)
Overall Status
Completed
CT.gov ID
NCT05493579
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Implant supported overdenture
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
"Impact of Mandibular Implant Supported Overdenture on Changes of Electromyographic Activity, Brain Activity, Cognitive Function, Nutrition and Depression Status."
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Complete denture then complete implant supported overdenture

Other: Implant supported overdenture
Implant supported overdenture compared to complete denture

Outcome Measures

Primary Outcome Measures

  1. Brain Activity (EEG) [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 Outcome Measures

  1. Cognitive Function (MMSE) [3 months]

    Cognitive function will be assessed using the Mini-Mental State Examination (MMSE) questionnaire. The MMSE set, with a total score of 30, assesses different domains of cognitive function. The MMSE comprises 30 questions, with 10 devoted to orientation; three items requiring registration of new information; five questions addressing attention and calculation; three recall items; eight items assessing language skills; and one construction question. Any score of 24 or more (out of 30) indicates normal cognition. Scores below this indicate severe (9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment.

Other Outcome Measures

  1. Muscle Activity (EMG) [3 months]

    The highest EMG activity in the masseter muscle and the anterior temporalis muscle will be calculated during the maximum clenching, maximal voluntary contraction (MVC) in the intercuspal position. The EMG signals will be stored and analyzed as root mean square (RMS) values expressed in microvolts (μV) and the mean amplitude of the motor unit potential (MUP) will be calculated in microvolts (μV).

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 69 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry. AL Azhar University for Girls, Cairo, Egypt. Cairo Egypt

Sponsors and Collaborators

  • Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Noha Taha Kamel Taha Alloush, Assistant Lecturer, Misr International University
ClinicalTrials.gov Identifier:
NCT05493579
Other Study ID Numbers:
  • REC-PR-21-08
First Posted:
Aug 9, 2022
Last Update Posted:
Aug 9, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 9, 2022