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

Not Applicable

Completed

• Conditions: Implant Supported Overdenture
• Interventions: Other: Implant supported overdenture

• Registration Number: NCT05493579
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-07-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-09
• Study First Submitted QC: 2022-08-07
• Last Update Submitted: 2022-08-07
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Complete denture then complete implant supported overdenture	Implant supported overdenture	-

Primary Outcome Measures

Name	Time	Method
Brain Activity (EEG)	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 Outcome Measures

Name	Time	Method
Cognitive Function (MMSE)	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.

Trial Locations

Locations (1)

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