The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

Completed

• Conditions: Diabete Type 2
• Interventions: 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

• Registration Number: NCT06188572
• Lead Sponsor: Bandırma Onyedi Eylül University

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.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-15
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Mandibular Function Disorder Questionnaire	Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
Diabetes Mellitus	Michigan Neuropathy Screening Instrument	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.
Diabetes Mellitus	Numeric Pain Scale	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.
Healthy	Numeric Pain Scale	Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
Diabetes Mellitus	Fonseca Anamnestic Index	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.
Diabetes Mellitus	Mandibular Function Disorder Questionnaire	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.
Healthy	Michigan Neuropathy Screening Instrument	Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
Healthy	Fonseca Anamnestic Index	Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
Healthy	Ferrans&Powers Quality of Life Index Diabetes Version	Age and sex homogenous healthy individuals without a diagnosis of DM were included in the control group
Diabetes Mellitus	Ferrans&Powers Quality of Life Index Diabetes Version	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.

Primary Outcome Measures

Name	Time	Method
Maximum pain-free mouth opening	May 2023- November 2023	The maximum pain-free mouth opening was recorded using a 15 cm ruler
Michigan Neuropathy Screening Instrument	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	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	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	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	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.

Trial Locations

Locations (1)

Bandirma Onyedi Eylul University; 🇹🇷 Balıkesir, Bandirma, Turkey