Temporomandibular Dysfunction in Patients With Diabetic Foot Ulcers

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Deglutition Disorders
Diabetic Foot
Diabetic Foot Ulcer
Foot Ulcer
Swallowing Disorder
Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Ulcer

Clinical Trial Details

NCT number	NCT06067022
Study type	Observational [Patient Registry]
Source	Harran University
Contact
Status	Completed
Phase
Start date	January 5, 2023
Completion date	July 5, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04497805` - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers	Phase 2
Withdrawn	`NCT03675269` - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:	N/A
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Not yet recruiting	`NCT06439667` - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting	`NCT05608187` - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers	Phase 2
Not yet recruiting	`NCT06278935` - Lifestyle Tailored Offloading for Diabetic Foot Ulcers	N/A
Not yet recruiting	`NCT06437028` - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.	N/A
Withdrawn	`NCT05024656` - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers	N/A
Terminated	`NCT02202668` - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers	N/A
Terminated	`NCT01966380` - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia	Phase 2
Completed	`NCT01951768` - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection	Phase 4
Completed	`NCT01657474` - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers	N/A
Active, not recruiting	`NCT00389636` - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	N/A
Completed	`NCT01181440` - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers	Phase 3
Enrolling by invitation	`NCT05888259` - Plantar Pressure Distribution in Diabetic Foot Ulcer	N/A
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting	`NCT05877378` - Efficacy of PICO Single-use System in Chronic Ulcers	N/A
Recruiting	`NCT06037369` - The Short Message-based Customized Standardized	N/A
Completed	`NCT03312595` - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)	N/A
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A