An interventional study of Implant supported overdenture in Implant Supported Overdenture, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 65 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-09.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Other: Implant supported overdenture
Implant supported overdenture compared to complete denture
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.
Time frame: 3 months
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.
Time frame: 3 months
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).
Time frame: 3 months
Plan to share: Undecided
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Ran from Oct 2020 to primary completion in Apr 2021, 6 months.
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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