## Protocol Section
### Identification Module
**NCT ID:** NCT05493579

**Brief Title:** Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain Activity

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

#### Organization Study ID Info
**ID:** REC-PR-21-08
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2021-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-10-01

**Type:** ACTUAL

**Status Verified Date:** 2022-01

#### Study First Post Date
**Date:** 2022-08-09
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-09
**Study First Submit QC Date:** 2022-08-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Azhar University

#### Responsible Party

**Investigator Affiliation:** Misr International University

**Investigator Full Name:** Noha Taha Kamel Taha Alloush

**Investigator Title:** Assistant Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Implant Supported Overdenture

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Implant supported overdenture

**Label:** Complete denture then complete implant supported overdenture

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Complete denture then complete implant supported overdenture

**Description:** Implant supported overdenture compared to complete denture

**Name:** Implant supported overdenture

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** 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).

**Measure:** Muscle Activity (EMG)

**Time Frame:** 3 months

#### Primary Outcomes

**Description:** 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.

**Measure:** Brain Activity (EEG)

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Cognitive Function (MMSE)

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 69 Years

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

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

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
