Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

September 27, 2023 updated by: Fatih Enzin, Harran University

Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers: What Could Be the Predictors?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was planned in an observational case-control study design. 84 participants were included. Individuals who signed the Informed Consent Form were included in the study. Individuals aged between 46-80 (min-max) who were diagnosed with type 2 DM and DFU in Harran University Research and Application Hospital Endocrinology Polyclinic were included in the study group, and healthy individuals aged 37-85 (min-max) without a diagnosis of DM were included in the control group. Among the exclusion criteria for all individuals from the study, the Mini-Mental Test score should be below 24, history of psychiatric illness, cancer, neurological problems, congenital anomalies, musculoskeletal problems, having a systemic disease, facial paralysis, undergoing surgery due to spine, abdomen and/or TMJ problem and receiving any treatment related to the spine and TMJ in less than 6 months.

In the clinical evaluation of individuals with DFU about diabetes and ulcers; diabetes duration, HbA1C value, glycemic control adequacy, and peripheral arterial disease were recorded, monofilament test was performed for sensory evaluation. Ulcer type and duration were recorded, and ulcer area was measured. Individuals' quality of life was evaluated with the Ferran Powers Quality of Life Index. In the evaluation of oral health in all participants; burning mouth syndrome, dry mouth sensation, tooth loss, tooth decay, and intraoral lesions were questioned.

Participants' pain reports were evaluated using the Numerical Rating Scale (NRS).

Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10).

Participants' TMJ disorders were evaluated using the Fonseca Anamnestic Index.

Participants' mandibular dysfunctions were evaluated using the Mandibular Function Disorder Questionnaire .

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Haliliye
      • Sanliurfa, Haliliye, Turkey, 63200
        • Fatih Enzin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Planned measurements and scales will be applied
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
Planned measurements and scales will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular Dysfunction
Time Frame: baseline
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life assessment
Time Frame: baseline
Quality of life is an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The participants' quality of life was evaluated using the Ferrans&Powers Quality of Life Index Diabetes Version.The Quality of Life Assessment Index consists of two parts and a total of 68 items. In the first part, in 6-point Likert order (1=not at all satisfied, 6=very satisfied) the patient's satisfaction/pleasure in various areas of life; In the second part (1=not at all important, 6=very important) the importance levels of various life areas of the patient are questioned. It is scored in the categories of health and functional capacity, socioeconomic status, psychological belief status, family status, and total quality of life. A high score indicates a good quality of life.
baseline
Swallowing Disorders
Time Frame: baseline
Swallowing disorders (Dysphagia) is the medical term for swallowing difficulties. Some people with dysphagia have problems swallowing certain foods or liquids, while others can't swallow at all. Participants' swallowing disorders were evaluated using the Eating Assessment Tool (EAT-10). The scale, which evaluates the symptoms and severity of oropharyngeal swallowing disorder and is valid and reliable, consists of 10 questions. Each question is scored between '0' (no problem) and '4' (serious problem). A total score of 3 and above on the scale between 0-40 indicates a swallowing problem.
baseline
Pain assessment
Time Frame: baseline
Participants' pain reports were evaluated using the Numerical Rating Scale (NRS). It is a simple, valid, and reliable method that is frequently used in measuring the severity of pain in the clinic. 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 he feels in the TMJ region
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Investigators

  • Principal Investigator: Fatih Enzin, asst prof dr, Harran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Actual)

June 5, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fatihenzin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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