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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379609
Other study ID # 2017/410
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date January 10, 2019

Study information

Verified date May 2020
Source Bahçesehir University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date January 10, 2019
Est. primary completion date November 3, 2018
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Presence of muscle-related temporomandibular disorder

Exclusion Criteria:

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Masticatory efficiency
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.

Locations

Country Name City State
Turkey Ezgi Yüceer Çetiner Istanbul In The USA Or Canada, Please Select...

Sponsors (2)

Lead Sponsor Collaborator
Bahçesehir University Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary masticatory efficiency Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group and experimental group 6 weeks
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