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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554199
Other study ID # 16-086
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date July 1, 2019

Study information

Verified date September 2020
Source National Research Center, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Missing Posterior Occlusal Contact

Intervention

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.

Locations

Country Name City State
Egypt National Research Centre Cairo Dokki

Sponsors (1)

Lead Sponsor Collaborator
National Research Center, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain activity measurement in controlled type 2 diabetic patients wearing RPD. RPDs were fabricated for each participant using thermoplastic resin. The brain activity was assessed using EEG by measuring the alpha waves (Da/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.
Primary Cognitive function assessment in controlled type 2 diabetic patients wearing RPD. 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.