The Effect of Peripheral Neuropathy Symptoms on Temporomandibular Joint Functionality

Diabete Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06188572
• Other study ID #: HRU/23.04.15
• Status: Completed
• Start date: May 1, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: January 2024
• Source: Bandirma Onyedi Eylül University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Peripheral Nervous System Diseases

Intervention

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.
• 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.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylul University	Balikesir	Bandirma

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Michigan Neuropathy Screening Instrument	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	May 2023- November 2023
Primary	Numeric Pain Scale	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	May 2023- November 2023
Primary	Maximum pain-free mouth opening	The maximum pain-free mouth opening was recorded using a 15 cm ruler	May 2023- November 2023
Primary	Mandibular Function Disorder Questionnaire	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.	May 2023- November 2023
Primary	Fonseca Anamnestic Index	This scale includes 10 questions. The presence of TMD is accepted in those with a score of 25. High score indicates increased dysfunction.	May 2023- November 2023
Primary	Ferrans&Powers Quality of Life Index Diabetes Version	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	May 2023- November 2023