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Completed

NCT Number: NCT05493579

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

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.

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Key information

Conditions

Implant Supported Overdenture

Age range

65 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant supported overdenture

Other

Implant supported overdenture compared to complete denture

Primary outcomes

  1. Brain Activity (EEG)

    Time frame: 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 outcomes

  1. Cognitive Function (MMSE)

    Time frame: 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 outcomes

  1. Muscle Activity (EMG)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 9, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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