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NCT Number: NCT06188572

The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

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.

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Key information

Conditions

Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

48 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bandirma Onyedi Eylul University

Balıkesir, Bandirma, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

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.

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.

Primary outcomes

  1. 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

  2. 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

  3. Maximum pain-free mouth opening

    Time frame: May 2023- November 2023

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

  4. 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.

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Bandırma Onyedi Eylül University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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