The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality
January 2, 2024 updated by: Hazel Çelik Güzel, Bandırma Onyedi Eylül University
The Effect of Diabetic Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality in Patients With Type 2 Diabetes
The aim of this observational case-control study was to investigate the effect of diabetic peripheral neuropathy symptoms on temporomandibular joint functionality in patients with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Detailed Description
The number of participants planned to be included in the study was decided with the G-Power programme. While calculating the number of individuals to be included in the study, it was calculated that the sample size to obtain an effect size of 0.6 for the purpose of evaluation within the 95% confidence interval in a way to provide 80% study power at 5% Type 1 and 20% Type 2 error limits should be 74 (n=37) individuals. This study included 70 individuals (DM study group=40 individuals, control group=30 individuals).
Peripheral neuropathy symptoms of all participants were evaluated with the Michigan Neuropathy Screening Test. In the evaluation of TMJ functionality, the presence of pain, maximum pain-free mouth opening, mandibular dysfunction and dysfunction were assessed with the help of scales. Duration of diabetes mellitus was recorded and quality of life was evaluated with Ferran Powers Quality of Life Index.
Study Type
Observational
Enrollment (Actual)
70
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
-
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Bandirma
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Balıkesir, Bandirma, Turkey
- Bandirma Onyedi Eylül University
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
The study group included individuals aged between 48-78 (min-max) years who were diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital, while the control group included age and gender homogeneous healthy individuals without a diagnosis of DM.
Description
Inclusion Criteria:
- Individuals diagnosed with type 2 DM
Exclusion Criteria:
- Having diabetic foot ulcer,
- Mini Mental Test score below 24,
- History of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic disease, facial paralysis, surgical operation related to spine, abdomen and/or TMJ problem
- Receiving any treatment related to spine and TMJ in less than 6 months
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diabetes Mellitus
The study group included individuals aged 48-78 (min-max) years, diagnosed with type 2 DM in the treatment units of Harran University Training and Research Hospital.
|
A two-step test consisting of symptom questionnaire and physical examination was used.
The symptom questionnaire includes 15 questions about the legs and feet.
Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests.
In this simple method, which is frequently used to measure pain intensity in the clinic and whose validity and reliability have been demonstrated, the participant is asked to mark a number on a 10 cm scale with numbers ranging from "0" (no pain) to "10" (unbearable pain) for the pain.
This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function
This scale, which is valid and reliable as a TMJ disorder assessment tool, includes 10 questions.
The presence of TMD is accepted in those with a score of 25.
This index consists of two parts and a total of 68 items.
A high score indicates a good quality of life.
|
|
Healthy
Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
|
A two-step test consisting of symptom questionnaire and physical examination was used.
The symptom questionnaire includes 15 questions about the legs and feet.
Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests.
In this simple method, which is frequently used to measure pain intensity in the clinic and whose validity and reliability have been demonstrated, the participant is asked to mark a number on a 10 cm scale with numbers ranging from "0" (no pain) to "10" (unbearable pain) for the pain.
This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function
This scale, which is valid and reliable as a TMJ disorder assessment tool, includes 10 questions.
The presence of TMD is accepted in those with a score of 25.
This index consists of two parts and a total of 68 items.
A high score indicates a good quality of life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum pain-free mouth opening
Time Frame: May 2023- November 2023
|
The maximum pain-free mouth opening was recorded using a 15 cm ruler
|
May 2023- November 2023
|
|
Mandibular Function Disorder Questionnaire
Time Frame: May 2023- November 2023
|
This scale evaluating mandibular dysfunction consists of two dimensions and 17 questions.A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.
|
May 2023- November 2023
|
|
Ferrans&Powers Quality of Life Index Diabetes Version
Time Frame: May 2023- November 2023
|
The Quality of Life Assessment Index consists of two parts and a total of 68 items.
A high score indicates a good quality of life
|
May 2023- November 2023
|
|
Michigan Neuropathy Screening Instrument
Time Frame: May 2023- November 2023
|
The symptom questionnaire includes 15 questions about the legs and feet. Physical examination includes assessment of the appearance of the feet, Achilles reflex, thumb vibration and monofilament tests. High score indicates increased neuropathy |
May 2023- November 2023
|
|
Numeric Pain Scale
Time Frame: May 2023- November 2023
|
The participant is asked to mark a number on a 10 cm scale, on which numbers are shown in the range of "0" (no pain) to "10" (unbearable pain) for the pain.
High score indicates increased pain
|
May 2023- November 2023
|
|
Fonseca Anamnestic Index
Time Frame: May 2023- November 2023
|
This scale includes 10 questions.
The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.
|
May 2023- November 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2023
Primary Completion (Actual)
November 1, 2023
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Actual)
January 3, 2024
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRU/23.04.15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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