The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

NCT ID: NCT06188572

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-11-15

Brief Summary

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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

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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.

Conditions

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Diabete Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

Michigan Neuropathy Screening Instrument

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Michigan Neuropathy Screening Instrument

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Interventions

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Michigan Neuropathy Screening Instrument

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.

Intervention Type OTHER

Numeric Pain Scale

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.

Intervention Type OTHER

Mandibular Function Disorder Questionnaire

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

Intervention Type OTHER

Fonseca Anamnestic Index

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.

Intervention Type OTHER

Ferrans&Powers Quality of Life Index Diabetes Version

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bandırma Onyedi Eylül University

OTHER

Sponsor Role lead

Responsible Party

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Hazel Çelik Güzel

Assist. Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bandirma Onyedi Eylul University

Balıkesir, Bandirma, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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HRU/23.04.15

Identifier Type: -

Identifier Source: org_study_id

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