Missing Posterior Occlusal Contact Clinical Trial
Official title:
Evaluation of Changes in Brain Activity and Cognitive Function of Diabetic Patients Wearing Removable Partial Dentures
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 |
Verified date | September 2020 |
Source | National Research Center, Egypt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | National Research Centre | Cairo | Dokki |
Lead Sponsor | Collaborator |
---|---|
National Research Center, Egypt |
Egypt,
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. |