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

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

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 Overview

• Status: Completed
• Conditions: Implant Supported Overdenture
• Intervention / Treatment: Other: Implant supported overdenture

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry. AL Azhar University for Girls, Cairo, Egypt.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 69 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complete denture then complete implant supported overdenture	Other: Implant supported overdenture; Implant supported overdenture compared to complete denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Activity (EEG)	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function (MMSE)	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Activity (EMG)	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).	3 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: REC-PR-21-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No