Brain and Cognitive Function of Patients With RPD

September 12, 2020 updated by: Asmaa Nabil Elboraey, National Research Centre, Egypt

Evaluation of Changes in Brain Activity and Cognitive Function of Diabetic Patients Wearing Removable Partial Dentures

To evaluate the influence of restoring lost posterior occlusal contacts with removable partial denture (RPD) on the brain activity and cognitive function in controlled type 2 diabetic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Cairo, Dokki, Egypt, 12622
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Loss of posterior occlusal contact unilaterally or bilaterally in both maxilla and mandible.
  • No previous partial dentures experience.
  • Nonsmokers.
  • Skeletally Angle's class I.
  • Controlled type 2 diabetes.

Exclusion Criteria:

  • History of brain diseases (e.g. cerebral infarction, and Alzheimer's).
  • Neuromuscular disorders.
  • Temporomandibular joint disorder.
  • Psychiatric illness.
  • Participants with parafunctional oral habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EEG and MMSE measurements before receiving RPD
EEG and MMSE were measured for all participant before wearing the removable partial dentures.
Device: Flexible partial denture
removable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear.
EXPERIMENTAL: EEG and MMSE measurements after receiving RPD
EEG and MMSE were measured for all participant after wearing the removable partial dentures
Device: Flexible partial denture
removable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activity measurement in controlled type 2 diabetic patients wearing RPD.
Time Frame: For each participant the RPD should be worn for one month.
RPDs were fabricated for each participant using thermoplastic resin. The brain activity was assessed using EEG by measuring the alpha waves (Dα/Hz) in controlled type 2 diabetic patients wearing RPDs. EEG records were obtained before denture delivery and one month after denture wear.
For each participant the RPD should be worn for one month.
Cognitive function assessment in controlled type 2 diabetic patients wearing RPD.
Time Frame: For each participant the RPD should be worn for one month.
For the same participates the cognitive function was assessed via MMSE questionnaire. MMSE consists of 12 questions with maximum scoring of 30. The measurements were obtained before denture delivery and one month after denture wear.
For each participant the RPD should be worn for one month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

May 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

August 29, 2020

First Submitted That Met QC Criteria

September 12, 2020

First Posted (ACTUAL)

September 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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