NCT04379609

Brief Summary

Temporomandibular disorders (TMD) are defined by pain in the temporomandibular joint (TMJ) and related tissues, limitations in the movements of the lower jaw, and TMJ noises.1,2 TMD are classified into four groups as temporomandibular joint disorders, masticatory muscle disorders, headache attributed to TMD and associated structures.3,4 Of these, masticatory muscle disorders are the most common TMD subtype seen in dental clinics.5-7 In general, two major symptoms are seen associated with masticatory muscle disorders: Pain and dysfunction. Pain is the vast majority of complaints about masticatory muscle disorders. The other important complaint is dysfunction, which occurs as a limitation in the opening range of the mandible.8 It is known that individuals with experimental muscle pain are slower than healthy individuals when biting hard food and show lower maximum voluntary clenching capacity.9 Also, it has been reported that the maximum bite force decreased in patients with temporomandibular disorders.10 These consequences directly affect patients' quality of life. Therefore, rehabilitation of limited masticatory functions is one of the important therapeutic goals for TMD patients.11 In TMD patients, masticatory functions can be measured objectively with bite force, bite force endurance, electromyography, and jaw kinematics, etc. Another objective method that can be used to determine masticatory functions is the masticatory efficiency test. In the literature, there are few studies that measure masticatory efficiency in TMD patients.12-16 Only two of these studies investigated the effect of TMD treatment and used the sieve method to measure masticatory efficiency.15,16 Although the sieve method is considered the gold standard, the procedure is complex and time consuming.17,18 To eliminate these disadvantages, masticatory efficiency measurement with two-color chewing gum tests which are simple and do not require special equipment or training can be used. The effect of many different conditions and treatments on masticatory efficiency was evaluated with this method.19 However, to our knowledge, there is no study in the literature evaluating TMD treatment with this method. The aim of this study was to compare the masticatory efficiency with a two-color chewing gum test before and after treatment of the masticatory muscle-related temporomandibular disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

May 5, 2020

Last Update Submit

May 6, 2020

Conditions

Keywords

chewing efficiencymasticatory efficiencymasticatory musclesmasticatory performancetemporomandibular disorders

Outcome Measures

Primary Outcomes (1)

  • masticatory efficiency

    Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group and experimental group

    6 weeks

Study Arms (2)

Employees and students

The control group was selected from among the employees and students of the faculty of dentistry to represent the general population without any temporomandibular disorder (TMD).

Other: Masticatory efficiency

Patients

Patients who were referred to the Ondokuz Mayıs University Faculty of Dentistry Department of Prosthodontics with a complaint of pain in the chewing muscles were enrolled in this study.

Other: Masticatory efficiency

Interventions

Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group, before and after treatment in the experimental group.21 Commercial two-color chewing gum was used.The gum was left on the patient's tongue and he/she was asked to chew 20 times naturally. After chewing, the gum was put in a transparent plastic bag and squeezed to 1 mm. Both sides of the sample were scanned at 300 dpi resolution on a desktop scanner (HP Deskjet, California, USA) in the same day to prevent the colors from deteriorating due to saliva. For each patient, two sides of scanned images were processed in ViewGum software (version 1.4, Dhal Software, Kifissia, Greece, www.dhal.com) using the method of Halozenitis et al. (2013).22 The value of VOH (variance of hue) was taken as the value of chewing activity. The highness of this value indicates low masticatory efficiency.

Employees and studentsPatients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

21 patients who were referred to the Ondokuz Mayıs University Faculty of Dentistry Department of Prosthodontics with a complaint of pain in the chewing muscles were enrolled in this study. The control group was selected from among the employees and students of the faculty of dentistry to represent the general population without any temporomandibular disorder (TMD).

You may qualify if:

  • Presence of muscle-related temporomandibular disorder

You may not qualify if:

  • Patients under the age of 18, who had a missing tooth (except 3rd molars) or crown-bridge restorations, any intra-articular temporomandibular disorder were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ezgi Yüceer Çetiner

Istanbul, In the USA Or Canada, Please Select..., 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

February 1, 2017

Primary Completion

November 3, 2018

Study Completion

January 10, 2019

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations