Brain and Cognitive Function of Patients With RPD

Sponsor

National Research Centre, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT04554199

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Missing Posterior Occlusal Contact	Device: Flexible partial denture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Participants, as well as the investigating dentist are blind to the result obtained from the EEG recording. The statistician is also unaware of the EEG .

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

May 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Brain activity measurement in controlled type 2 diabetic patients wearing RPD. [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.
Cognitive function assessment in controlled type 2 diabetic patients wearing RPD. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Research Centre	Cairo	Dokki	Egypt	12622

Sponsors and Collaborators

National Research Centre, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt

ClinicalTrials.gov Identifier:

NCT04554199

Other Study ID Numbers:

16-086

First Posted:

Sep 18, 2020

Last Update Posted:

Sep 18, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt

Removable partial dentures

Electro-encephalogram

Mini mental state examination

Controlled type 2 diabetes.

Study Results

No Results Posted as of Sep 18, 2020