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Clinical Trials/NCT06669910
NCT06669910
Completed
Not Applicable

Investıgatıon of Temporomandıbular Dysfunctıon in Patıents Wıth Breast Cancer-Related Lymphedema

arife akbulut1 site in 1 country38 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
arife akbulut
Enrollment
38
Locations
1
Primary Endpoint
temporomandibular dysfunction
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Socio-demographic characteristics of 38 individuals included in the study were recorded. Patients were divided into stage 0, 1 and 2 groups according to their LÖ stage and mild, moderate and advanced groups according to their TMD levels. In the evaluation of severity of lymphedema, Symptoms and Signs of TMD, pain threshold and tolerance assessment and normal range of motion, anxiety and depression, posture analysis environmental measurement, Craniomandibular Dysfunction Index for Clinical, Visual Analogue Scale (VAS) and algometer , goniometer and inclinometer, Turkish version of the Hospital Anxiety and Depression Scale (HAD) ,photogrammetric assessment method and inclinometer were used

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
July 31, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
arife akbulut
Responsible Party
Sponsor Investigator
Principal Investigator

arife akbulut

LECTURER

Ankara Yildirim Beyazıt University

Eligibility Criteria

Inclusion Criteria

  • Female patients aged 18-75 years who were treated for unilateral breast cancer and developed breast cancer-related LE were included in the study

Exclusion Criteria

  • Patients with general joint diseases affecting the head and neck region that may cause TMD (e.g. rheumatoid arthritis),
  • jaw fracture,
  • trauma or orthognathic surgery history,
  • cervical disc herniation,
  • congenital disease,
  • facial paralysis,
  • patients who have been treated for TMD for the last 3 months and patients who use antidepressant drugs were excluded.

Outcomes

Primary Outcomes

temporomandibular dysfunction

Time Frame: through study completion, an average of 1 year

The Clinical Craniomandibular Dysfunction Index (CDI) was used. CDI consists of five components including limited mandibular normal joint motion (RMJ), pain during mandibular RMJ, pain during TMJ palpation, pain during palpation of masticatory muscles and pain during mandibular function. 3 points can be given for each component as 0, 1 or 5 points and individuals are graded as no TMD (0 points), mild TMD (1-4 points), moderate TMD (5-9 points) and severe TMD (10-25 points) according to the scores received.

lymhedema

Time Frame: through study completion, an average of 1 year

It was determined according to the criteria determined by the International Lymphology Association . To determine the severity of LE, circumference measurements were taken from both arms at 4 cm intervals. If the difference between the two extremities was up to 1.5 cm, it was classified as "normal", between 1.5-3 cm as "mild", between 3-5 cm as "moderate" and over 5 cm as "severe" LE

Secondary Outcomes

  • pain(through study completion, an average of 1 year)
  • posture(through study completion, an average of 1 year)
  • Measurement of range of motion of cervical joints and shoulder joint(through study completion, an average of 1 year)
  • anxiety-depression(through study completion, an average of 1 year)

Study Sites (1)

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