Temporomandibular DisorderNCT04379609
Effects of Temporomandibular Disorder on Masticatory Efficiency
An observational study of Temporomandibular Disorder, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Masticatory efficiency
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Presence of muscle-related temporomandibular disorder
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ezgi Yüceer Çetiner
Istanbul, In the USA Or Canada, Please Select..., 34734
About this study
Official title: Masticatory Efficiency Before and After Muscle-Related Temporomandibular Disorder Treatment
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.
- Conditions
- Temporomandibular Disorder
- Being tested
- Masticatory efficiency
- Keywords
- chewing efficiency, masticatory efficiency, masticatory muscles, masticatory performance, temporomandibular disorders
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masticatory efficiencyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Masticatory efficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
masticatory efficiency
Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group and experimental group
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Feb 2017
- Primary completion3 Nov 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Ezgi Yüceer Çetiner, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379609
- Sponsor's protocol ID
- 2017/410
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masticatory Efficiency Before and After Muscle-Related Temporomandibular Disorder Treatment
- ClinicalTrials.gov ID
- NCT04379609
- Acronym / sponsor ID
- 2017/410
- Conditions
- Temporomandibular Disorder
- Keywords
- chewing efficiency, masticatory efficiency, masticatory muscles, masticatory performance, temporomandibular disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Employees and students | – | Other: Masticatory efficiencyThe 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). |
| Patients | – | Other: Masticatory efficiencyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Presence of muscle-related temporomandibular disorder
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masticatory efficiencyTwo-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. | Other | Employees and students, Patients |
Primary outcome
masticatory efficiency
Time frame: 6 weeks
Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group and experimental group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Disorder
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
masticatory efficiency (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.