NCT06188572

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
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Bandırma Onyedi Eylül University · Academic / Other
• Sex: All
• Age: 48 Years – 78 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabete Type 2

Interventions

Type	Name	Description
OTHER	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.
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.
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
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.
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-11-01
• Completion: 2023-11-15
• First posted: 2024-01-03
• Last updated: 2024-01-05

Locations

1 site across 1 country: Turkey (Türkiye)