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

NCT ID: NCT05493579

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-01

Brief Summary

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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

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Conditions

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Implant Supported Overdenture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Complete denture then complete implant supported overdenture

Group Type EXPERIMENTAL

Implant supported overdenture

Intervention Type OTHER

Implant supported overdenture compared to complete denture

Interventions

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Implant supported overdenture

Implant supported overdenture compared to complete denture

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Noha Taha Kamel Taha Alloush

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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REC-PR-21-08

Identifier Type: -

Identifier Source: org_study_id

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