Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

NCT06067022 | Completed DMC

• 1 other identifier: fatihenzin
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational study is to investigate the effects of the type, area and duration of ulceration on jaw pain, mandibular function limitation, TMD and swallowing in individuals with diabetic foot ulcers.The main questions it aims to answer are:

• Does the change in foot structure due to diabetic foot ulcer have an effect on the temporomandibular jointand swalloving?
• What are the determinants of tempomandibular dysfunction in individuals with diabetic foot ulcers? Participants (both groups) will be evaluated for quality of life, jaw functionality, mandibular dysfunction, oropharyngeal swallowing disorder, pain and diabetes complications.

Conditions

Diabetic Foot Ulcer; Temporomandibular Disorder; Swallowing Disorder

Keywords

Diabetes Mellitus; Diabetic Foot Ulcer; TMJ; Oral Health; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Temporomandibular Dysfunction

  An umbrella term covering pain and dysfunction of the muscles of mastication (the muscles that move the jaw) and the temporomandibular joints (the joints which connect the mandible to the skull). Temporomandibular Dysfunction was assessed using the Mandibular Function Disorder Questionnaire. This valid and reliable scale evaluating mandibular dysfunction consists of two dimensions and 17 questions. The first 11 items form the Functional Capacity dimension, and the next six items form the Nutrition dimension. Each question is scored from '0' (no difficulty) to '4' (very difficult or impossible without assistance). A high total score obtained from the questionnaire indicates a high level of impairment in jaw function.

  baseline

Secondary Outcomes (3)

• Quality of life assessment

  baseline

• Swallowing Disorders

  baseline

• Pain assessment

  baseline

Study Arms (2)

Study Group

42 patients with diabetic foot ulcers were included. For patients in this group, regarding diabetic foot; Sensory assessment, ulcer area and depth measurement, and diabetes management information were measured. Apart from these evaluations, quality of life, pain, mandibular function and oropharyngeal swallowing problems were evaluated.

Other: observation

Control Group

42 patients without diabetes were included. Patients in this group were evaluated for general health and quality of life, pain, mandibular function and oropharyngeal swallowing problems.

Other: observation

Interventions

observation OTHER

Planned measurements and scales will be applied

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Being over 18 years old
• Having been diagnosed with Type 2 diabetes for at least 10 years
• Not having a serious musculoskeletal, cardiac, neurological, etc. systemic disorder that may interfere with the research.
• Not having any communication problems

You may not qualify if:

• Having a diabetic foot ulcer
• Having a diagnosed psychiatric disease,
• Having had a temporomandibular joint operation,
• Having experienced direct or indirect trauma to the head-neck and spine area,
• Having had previous spine surgery,
• Having any mental problems,
• Having a neuromuscular problem that proves a systemic specific pathological condition such as malignant condition of the spine and/or TMJ, fracture, rheumatoid disease,
• Having had facial paralysis less than 1 year ago,
• Being diagnosed with TMD,
• Having received TMJ-related physical therapy treatment in less than 6 months.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Fatih Enzin

Sanliurfa, Haliliye, 63200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Temporomandibular Joint Disorders; Deglutition Disorders; Diabetes Mellitus

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Fatih Enzin, asst prof dr

  Harran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 4, 2023
• Study Start: January 5, 2023
• Primary Completion: June 5, 2023
• Study Completion: July 5, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

TU (1)