Brain and Cognitive Function of Patients With RPD

Study Overview
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Brief Summary
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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

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

Conditions
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Missing Posterior Occlusal Contact

Intervention / Treatment
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* Device: Flexible partial denture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EEG and MMSE measurements before receiving RPD<br>EEG and MMSE were measured for all participant before wearing the removable partial dentures. | Device: Flexible partial denture<br>* 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.<br>|
| Experimental: EEG and MMSE measurements after receiving RPD<br>EEG and MMSE were measured for all participant after wearing the removable partial dentures | Device: Flexible partial denture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Removable partial dentures, Electro-encephalogram, Mini mental state examination, Controlled type 2 diabetes.