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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05493579
Enrollment
10
Registered
2022-08-09
Start date
2020-10-01
Completion date
2021-07-01
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Supported Overdenture

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.

Interventions

Implant supported overdenture compared to complete denture

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 69 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Brain Activity (EEG)3 monthsAn 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

MeasureTime frameDescription
Cognitive Function (MMSE)3 monthsCognitive 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

MeasureTime frameDescription
Muscle Activity (EMG)3 monthsThe 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026