The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

NCT06188572 | Completed

• 1 other identifier: HRU/23.04.15
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Type 2

Keywords

diabetes mellitus; temporomandibular joint; neuropathy

Outcome Measures

Primary Outcomes (6)

• Michigan Neuropathy Screening Instrument

  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

  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

• Maximum pain-free mouth opening

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

  May 2023- November 2023

• Mandibular Function Disorder Questionnaire

  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

• Fonseca Anamnestic Index

  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

• Ferrans&Powers Quality of Life Index Diabetes Version

  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

Study Arms (2)

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.

Other: Michigan Neuropathy Screening Instrument; Other: Numeric Pain Scale; Other: Mandibular Function Disorder Questionnaire; Other: Fonseca Anamnestic Index; Other: Ferrans&Powers Quality of Life Index Diabetes Version

Healthy

Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group

Other: Michigan Neuropathy Screening Instrument; Other: Numeric Pain Scale; Other: Mandibular Function Disorder Questionnaire; Other: Fonseca Anamnestic Index; Other: Ferrans&Powers Quality of Life Index Diabetes Version

Interventions

Michigan Neuropathy Screening Instrument OTHER

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.

Diabetes Mellitus; Healthy

Numeric Pain Scale OTHER

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.

Diabetes Mellitus; Healthy

Mandibular Function Disorder Questionnaire OTHER

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

Diabetes Mellitus; Healthy

Fonseca Anamnestic Index OTHER

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.

Diabetes Mellitus; Healthy

Ferrans&Powers Quality of Life Index Diabetes Version OTHER

This index consists of two parts and a total of 68 items. A high score indicates a good quality of life.

Diabetes Mellitus; Healthy

Eligibility Criteria

• Age: 48 Years - 78 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Individuals diagnosed with type 2 DM

You may not qualify if:

• 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

Sponsors & Collaborators

• Bandırma Onyedi Eylül University: lead

Study Sites (1)

Bandirma Onyedi Eylul University

Balıkesir, Bandirma, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: May 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 15, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

TU (1)