Skip to main content
OpenTrials
Completed

NCT Number: NCT06669910

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Arife Akbulut

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

only assesment

Other

only assesment

Primary outcomes

  1. 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.

  2. 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

  1. pain

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

    The pain was assessed with the Visual Analog Scale (VAS) at rest and activity. Patients were asked to mark the point that best described their pain on a 10 cm line (0: no pain, 10: unbearable pain). The pain intensity with activity was assessed during mouth opening, mouth closing and 60 seconds of gum chewing. Patients were asked to chew gum using both sides for 60 seconds. At the end of this period, patients evaluated their pain in the TMJ according to the VAS

  2. posture

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

    Kyphosis and lordosis angles of the patients were measured with Baseline® Digital inclinometer while the patients were standing in a comfortable position. "Posture Analysis Method with Photography" was used.

  3. Measurement of range of motion of cervical joints and shoulder joint

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

    The measurements were made with a Baseline® universal goniometer with a plastic 360 degree quadrant. Flexion, extension, right-left lateral flexion and rotation angles for the cervical region, and flexion, abduction, external and internal rotation ROM angles for the shoulder joint were measured. The measurements were made in the sitting position for the cervical region and in the supine position for the shoulder. Each measurement was repeated 3 times and the average values were recorded.

  4. anxiety-depression

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

    The Turkish version of the Hospital Anxiety and Depression Scale (HAD) was used. HAD is a 4-point Likert-type scale with a score between 0 and 21, consisting of 14 questions, 7 of which evaluate anxiety and 7 of which evaluate depression.

Sponsors and collaborators

Lead sponsor

arife akbulut

Other

Collaborators

  • Gazi University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2024
First posted
Nov 1, 2024
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.