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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphedema
• Intervention / Treatment: Other: only assesment

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Arife Akbulut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Female patients who were treated for unilateral breast cancer and developed breast cancer-related LE

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
mild TMD	Other: only assesment; only assesment
moderate TMD	Other: only assesment; only assesment
advanced TMD	Other: only assesment; only assesment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
temporomandibular dysfunction	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.	through study completion, an average of 1 year
lymhedema	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	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain	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	through study completion, an average of 1 year
posture	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.	through study completion, an average of 1 year
Measurement of range of motion of cervical joints and shoulder joint	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.	through study completion, an average of 1 year
anxiety-depression	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: arife akbulut
• Collaborators: Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Joint Diseases; Jaw Diseases; Skin Diseases; Breast Diseases; Lymphatic Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: AYBU-AKBULUT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No