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The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06188572
Enrollment
70
Registered
2024-01-03
Start date
2023-05-01
Completion date
2023-11-15
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabete Type 2

Keywords

diabetes mellitus, temporomandibular joint, neuropathy

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.

Interventions

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.

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.

OTHERMandibular 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

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.

OTHERFerrans&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.

Sponsors

Bandırma Onyedi Eylül University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
48 Years to 78 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Michigan Neuropathy Screening InstrumentMay 2023- November 2023The 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
Numeric Pain ScaleMay 2023- November 2023The 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
Maximum pain-free mouth openingMay 2023- November 2023The maximum pain-free mouth opening was recorded using a 15 cm ruler
Mandibular Function Disorder QuestionnaireMay 2023- November 2023This 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 IndexMay 2023- November 2023This scale includes 10 questions. The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.
Ferrans&Powers Quality of Life Index Diabetes VersionMay 2023- November 2023The Quality of Life Assessment Index consists of two parts and a total of 68 items. A high score indicates a good quality of life

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026