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Clinical Trials/NCT06188572
NCT06188572
Completed
N/A

The Effect of Diabetic Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality in Patients With Type 2 Diabetes

Bandırma Onyedi Eylül University1 site in 1 country70 target enrollmentMay 1, 2023
ConditionsDiabete Type 2

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabete Type 2
Sponsor
Bandırma Onyedi Eylül University
Enrollment
70
Locations
1
Primary Endpoint
Maximum pain-free mouth opening
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
November 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bandırma Onyedi Eylül University
Responsible Party
Principal Investigator
Principal Investigator

Hazel Çelik Güzel

Assist. Prof. Dr

Bandırma Onyedi Eylül University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Maximum pain-free mouth opening

Time Frame: May 2023- November 2023

The maximum pain-free mouth opening was recorded using a 15 cm ruler

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

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

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

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.

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.

Study Sites (1)

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