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."
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 9, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedAugust 9, 2022
January 1, 2022
6 months
January 9, 2022
August 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Cognitive Function (MMSE)
3 months
Other Outcomes (1)
Muscle Activity (EMG)
3 months
Study Arms (1)
Complete denture then complete implant supported overdenture
EXPERIMENTALInterventions
Implant supported overdenture compared to complete denture
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry. AL Azhar University for Girls, Cairo, Egypt.
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
January 9, 2022
First Posted
August 9, 2022
Study Start
October 1, 2020
Primary Completion
April 1, 2021
Study Completion
July 1, 2021
Last Updated
August 9, 2022
Record last verified: 2022-01