BruxismNCT04363931
Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism
A study testing Manual Therapy and Kinesio Taping in people with Bruxism, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Bruxism is defined as a repetitive jaw-muscle activity characterized by tooth grinding or clenching accompanied with wearing of the teeth, and jaw muscle discomfort in the absence of a medical disorder . Bruxism has two distinct circadian manifestations: it can be nocturnal or diurnal. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- What is being tested?
- Manual Therapy and Kinesio Taping
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2019to 4 Apr 2020
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders
- Self-report of awake bruxism
Who cannot join
- Having more than 2 missing teeth
- The presence of removable partial dentures
- Having neurological, psychiatric or motor disorders
- Having any ongoing dental or physical therapy
- Active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Bruxism is defined as a repetitive jaw-muscle activity characterized by tooth grinding or clenching accompanied with wearing of the teeth, and jaw muscle discomfort in the absence of a medical disorder . Bruxism has two distinct circadian manifestations: it can be nocturnal or diurnal. Hypertrophy of the masseter muscle is an objective sign of bruxism. Additionally, fatigue or stiffness in the masticatory muscles, pain in the temporomandibular joint or headaches are subjective signs of bruxism. According to literature, 85% to 90% of the general population experience episodes of bruxism during their lives. Thus, finding an effective treatment method for bruxism is crucial.The aim of this study is to investigate the effects of two different physiotherapy approaches on the masseter muscle thickness and stiffness in patients with Bruxism.
Read the detailed description
There is no certain treatment for Bruxism. However, the most recent recommendation is to follow the Multiple-P approach prior to medical drug regimens and invasive procedures. Different methods used in the conservative management of Bruxism are known as the "multiple-P" approach, which consists of; physiotherapy, plates, pep talk, pills and psychology . Physiotherapy generally focuses on two objectives: decreasing the adverse effects of bruxism to the masticatory muscles and increasing self-awareness regarding this habit. These studies involve different intervention such as massage of the masticatory and cervical muscles, electrotherapy, therapeutic exercises, taping interventions or relaxation therapies . However, literature regarding which physiotherapy intervention is the most effective in bruxism is not clear. Therefore patients in this study were randomly divided into one of two groups; manual therapy or kinesio taping. All patients were assessed at baseline, received 4 weeks of treatment and were assessed following the 4 weeks.
- Conditions
- Bruxism
- Being tested
- Manual Therapy, Kinesio Taping
- Keywords
- Bruxism, Manual Therapy, Kinesio Taping, Physiotherapy
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyProcedure or surgery
Participants in this group received 4 weeks of manual therapy and massage of the masticatory muscles intra and extra orally together with massage of the cervical muscles. Massage and Manual Therapy brings about benefits by increasing local circulation and decreasing muscle tonus . Additionally, stretching exercises aiming to decrease pain and elongate shortened masticatory muscle fibers by autogenic inhibition of the masseter muscle were performed.
Kinesio TapingProcedure or surgery
Participants in this group had an application of Kinesio Taping on the masseter muscles. The material used for bruxism Kinesio Taping application was Kinesio Tex Gold Finger Prints (Kinesio Holding Corporation, Albuquerque, USA), a 100% cotton, latex-free, 5-cm wide, elastic tape. Kinesio Taping placement was chosen according to principles described by Kase et al. Tapes were cut 2.5 cm in width (cut in half vertically from 5 cm width). Two strips of Kinesio Tape were crossed over the masseter muscle area with 0-5% tension in maximum stretched epidermis position. Web-cut strips epidermis-dermis-fascia technique were used. Tape was applied bilaterally after every session of manual therapy.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy | Experimental | Manual Therapy is a widely used physiotherapy modality which is known to be effective in the management of musculoskeletal problems . Manual Therapy is a passive, therapeutic approach used to target a variety of anatomical structures with the intent to create beneficial changes in the amount of pain a patient experiences. Manual Therapy includes joint mobilization, manipulation, or treatment of the soft tissues and is widely used to break fibrous adhesions, restore normal range of motion, reduce local ischemia, stimulate synovial fluid production, and reduce pain . Receives: Procedure: Manual Therapy |
| Kinesio Taping | Experimental | Kinesio tape is a type of elastic therapeutic tape that was developed which is used in many different situations with various aims. Advocates of Kinesio Tape state that it may promote different therapeutic objectives such as; improved circulation and lymphatic drainage, pain inhibition, reduction of delayed onset of muscle soreness or improvement in performance and coordination . Receives: Procedure: Kinesio Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Pressure Threshold of Masseter Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the masseter muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Measured: Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
Pain Pressure Threshold of Trapezius Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the trapezius muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Measured: Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
Pain Pressure Threshold of Temporalis Muscle
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the temporalis muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Measured: Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks
Secondary outcomes (1)
Sleep Quality
The Pittsburgh Sleep Quality Index is an index widely used to measure sleep quality. The Pittsburgh Sleep Quality Index is a self-reported questionnaire that includes 19 questions that when scored, are separated into seven domains. The seven domains are; perceived sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medications; and daytime dysfunction. Each domain is scored from 0-3 and a total score ranging from 0-21 can be obtained. A total score of; 0-4 indicates a good sleep quality, 5-10 indicates poor sleep quality and scores above 10 indicate a possible sleep disorder.
Measured: Change from Baseline Sleep Quality at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start7 Oct 2019
- Primary completion28 Feb 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Yazici, Gazi University
- Investigators
- Gokhan Yazici, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363931
- Sponsor's protocol ID
- GaziU2020
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism
- ClinicalTrials.gov ID
- NCT04363931
- Acronym / sponsor ID
- GaziU2020
- Conditions
- Bruxism
- Keywords
- Bruxism, Manual Therapy, Kinesio Taping, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 27 Apr 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.
Bruxism is defined as a repetitive jaw-muscle activity characterized by tooth grinding or clenching accompanied with wearing of the teeth, and jaw muscle discomfort in the absence of a medical disorder . Bruxism has two distinct circadian manifestations: it can be nocturnal or diurnal. Hypertrophy of the masseter muscle is an objective sign of bruxism. Additionally, fatigue or stiffness in the masticatory muscles, pain in the temporomandibular joint or headaches are subjective signs of bruxism. According to literature, 85% to 90% of the general population experience episodes of bruxism during their lives. Thus, finding an effective treatment method for bruxism is crucial.The aim of this study is to investigate the effects of two different physiotherapy approaches on the masseter muscle thickness and stiffness in patients with Bruxism.
Detailed description
There is no certain treatment for Bruxism. However, the most recent recommendation is to follow the Multiple-P approach prior to medical drug regimens and invasive procedures. Different methods used in the conservative management of Bruxism are known as the "multiple-P" approach, which consists of; physiotherapy, plates, pep talk, pills and psychology . Physiotherapy generally focuses on two objectives: decreasing the adverse effects of bruxism to the masticatory muscles and increasing self-awareness regarding this habit. These studies involve different intervention such as massage of the masticatory and cervical muscles, electrotherapy, therapeutic exercises, taping interventions or relaxation therapies . However, literature regarding which physiotherapy intervention is the most effective in bruxism is not clear. Therefore patients in this study were randomly divided into one of two groups; manual therapy or kinesio taping. All patients were assessed at baseline, received 4 weeks of treatment and were assessed following the 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy | Experimental | Procedure: Manual TherapyManual Therapy is a widely used physiotherapy modality which is known to be effective in the management of musculoskeletal problems . Manual Therapy is a passive, therapeutic approach used to target a variety of anatomical structures with the intent to create beneficial changes in the amount of pain a patient experiences. Manual Therapy includes joint mobilization, manipulation, or treatment of the soft tissues and is widely used to break fibrous adhesions, restore normal range of motion, reduce local ischemia, stimulate synovial fluid production, and reduce pain . |
| Kinesio Taping | Experimental | Procedure: Kinesio TapingKinesio tape is a type of elastic therapeutic tape that was developed which is used in many different situations with various aims. Advocates of Kinesio Tape state that it may promote different therapeutic objectives such as; improved circulation and lymphatic drainage, pain inhibition, reduction of delayed onset of muscle soreness or improvement in performance and coordination . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A Bruxism Diagnosis according to the criteria of the international classification for sleep disorders
- Self-report of awake bruxism
Key exclusion criteria (5 listed)
- Having more than 2 missing teeth
- The presence of removable partial dentures
- Having neurological, psychiatric or motor disorders
- Having any ongoing dental or physical therapy
- Active cancer
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 |
|---|---|---|
| Manual TherapyParticipants in this group received 4 weeks of manual therapy and massage of the masticatory muscles intra and extra orally together with massage of the cervical muscles. Massage and Manual Therapy brings about benefits by increasing local circulation and decreasing muscle tonus . Additionally, stretching exercises aiming to decrease pain and elongate shortened masticatory muscle fibers by autogenic inhibition of the masseter muscle were performed. | Procedure or surgery | Manual Therapy |
| Kinesio TapingParticipants in this group had an application of Kinesio Taping on the masseter muscles. The material used for bruxism Kinesio Taping application was Kinesio Tex Gold Finger Prints (Kinesio Holding Corporation, Albuquerque, USA), a 100% cotton, latex-free, 5-cm wide, elastic tape. Kinesio Taping placement was chosen according to principles described by Kase et al. Tapes were cut 2.5 cm in width (cut in half vertically from 5 cm width). Two strips of Kinesio Tape were crossed over the masseter muscle area with 0-5% tension in maximum stretched epidermis position. Web-cut strips epidermis-dermis-fascia technique were used. Tape was applied bilaterally after every session of manual therapy. | Procedure or surgery | Kinesio Taping |
Primary outcome
Pain Pressure Threshold of Masseter Muscle
Time frame: Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the masseter muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Pain Pressure Threshold of Trapezius Muscle
Time frame: Change from Baseline Pain Pressure Threshold of Trapezius Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the trapezius muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
Pain Pressure Threshold of Temporalis Muscle
Time frame: Change from Baseline Pain Pressure Threshold of Temporalis Muscle at 4 weeks
Pain Pressure Threshold was determined using a digital algometer (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA) which consists of a padded disc attached to a microprocessor control unit that measures peak force (Newton). The Pain Pressure Threshold of the temporalis muscle was assessed via the algometer. During Pain Pressure Threshold assessment, the researcher positioned the algometer on the trigger points of the respective muscle and increase the amount of pressure applied until the participant verbally informed the researcher when the sensation of pressure became pain. The applied pressure was read from the digital screen after each assessment.
1 secondary outcome
Sleep Quality
Time frame: Change from Baseline Sleep Quality at 4 weeks
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 27 Apr 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers
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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.
Gokhan Yazici, PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Kinesio Taping in people with Bruxism, run by Gazi 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 2 inclusion and 5 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 27 Apr 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?
Pain Pressure Threshold of Masseter Muscle (time frame: Change from Baseline Pain Pressure Threshold of Masseter Muscle at 4 weeks). The study lists 3 primary outcomes in all. 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 27 Apr 2020.