Kinesiology TapingNCT06611358
The Effects of Kinesio Taping and Exercise Interventions in Individuals With Bruxism
A study testing Kinesiology Taping and Exercise and Convansionel Exercise in people with Kinesiology Taping and Bruxism, run by Istanbul Medipol University Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Bruxism is the unconscious act of grinding or clenching the teeth. It leads to hyperactivity of the masticatory muscles due to non-functional mandibular movements, which can result in pain symptoms and is, therefore, a significant factor contributing to changes in the temporomandibular joint. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Kinesiology Taping, Bruxism, Exercise
- What is being tested?
- Kinesiology Taping and Exercise and Convansionel Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 26 Aug 2023to 29 Nov 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of teeth clenching complaints
- Being between the ages of 20 and 50
- No history of major trauma to the Temporamandibular region
- No history of surgical operations on the temporomandibular joint
Who cannot join
- Individuals with conditions that can cause facial pain, such as sinusitis or trigeminal neuralgia
- Individuals with temporomandibular joint involvement secondary to inflammatory diseases
- Individuals with degenerative problems that restrict neck movements
- Individuals who have received treatment for bruxism in the last 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Medipol University
Istanbul, Beykoz, 34810
Istanbul Medipol University
Istanbul, 34820
About this study
Official title: Effect of Kinesio Taping and Exercise Interventions on Pain, Proprioception, Sleep, and Psychological Status in Individuals With Bruxism
Bruxism is the unconscious act of grinding or clenching the teeth. It leads to hyperactivity of the masticatory muscles due to non-functional mandibular movements, which can result in pain symptoms and is, therefore, a significant factor contributing to changes in the temporomandibular joint. While the beneficial effects of exercise and kinesio taping on temporomandibular dysfunction and bruxism have been validated by various studies in the literature, research investigating their impact on cervical awareness remains quite limited. Hence, the aim of this study is to examine the effects of kinesio taping in addition to exercise on pain, mandibular range of motion, sleep quality, depression levels, and cervical awareness in individuals with bruxism.
Read the detailed description
Bruxism is a parafunctional or unconscious act of grinding or clenching the teeth. The factors contributing to bruxism are thought to include joint and soft tissue injuries, genetic factors, fatigue, and stress. There is a consensus that the etiology of bruxism is multifactorial and originates from central mechanisms. Bruxism is a common parafunctional activity in the general population, occurring both during sleep and while awake. Daytime bruxism, which is more prevalent in women, affects approximately 20% of the adult population, while sleep bruxism affects around 10%. Overall, the prevalence of bruxism decreases with age, regardless of gender.
The treatment of bruxism aims to raise awareness of oral parafunctional behaviors, alleviate pain, establish a resting position for the temporomandibular joint, improve posture in the head and neck regions, restore muscle strength between affected muscles, and achieve pain-free range of motion. While there is no definitive treatment method, a variety of invasive (acupuncture, injections, surgery, etc.) and non-invasive (exercise, electrical stimulation, manual trigger point stimulation, taping, etc.) approaches are employed. In recent years, reversible non-invasive approaches have gained importance in treatment.
Taping and bandaging have long been part of physiotherapy practices as treatment methods. Kinesio® Tape is a latex-free, thin, cotton-based tape. Developed in Japan 25 years ago, Kinesio® Tape has become widely used in recent years, not only in the United States, Europe, and many other parts of the world but also in our country. The structure, thickness, and weight of the tape are similar to the physical properties of the skin, with a high degree of longitudinal elasticity. The tension levels of the tapes vary depending on the treatment purpose. The primary goal of the Kinesio taping method is to support healing by allowing pain-free movement. In the Kinesio taping method, the tape is applied around or over the muscles as needed to prevent muscle overactivity.
Psychological counseling and exercise are widely used techniques in the treatment of temporomandibular dysfunction (TMD) and have been shown to have positive outcomes in the literature. In a randomized controlled trial by Nimela et al., the efficacy of counseling and masticatory muscle exercises alone was found to be similar to that of stabilization splints in both pain relief and increasing active maximal mouth opening. In a study by Coşkun et al., the addition of kinesio taping to counseling and exercises resulted in significantly greater benefits in both the short and long term. While the beneficial effects of exercise and kinesio taping on TMD and bruxism have been confirmed in various studies, research investigating their impact on cervical awareness is quite limited. Therefore, the aim of this study is to examine the effects of kinesio taping, in addition to exercise, on pain, temporomandibular joint range of motion, sleep quality, depression levels, and cervical awareness in individuals with bruxism.
- Conditions
- Kinesiology Taping, Bruxism, Exercise
- Being tested
- Kinesiology Taping and Exercise, Convansionel Exercise
- Keywords
- kinesiology taping, Bruxism, exercise, temporamandibular disfunction
- Medical subject headings
- Bruxism, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesiology Taping and ExerciseOther
Individuals meeting the inclusion criteria will receive kinesio taping applied to the temporomandibular joint by a physiotherapist every three days for two weeks. The kinesio tape will be applied along the origin-insertion line with zero tension. In addition to the kinesio taping, participants will follow a exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol
Convansionel ExerciseOther
This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol.
| Study group | Role | What they receive |
|---|---|---|
| Kinesiology Taping Group | Experimental | Individuals meeting the inclusion criteria will have kinesio tape applied to the temporomandibular joint by a physiotherapist every three days for a duration of two weeks. In addition to the kinesio taping, participants will perform an at-home exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions. Receives: Other: Kinesiology Taping and Exercise |
| Conventional Group | Active comparator | Individuals meeting the inclusion criteria will not receive kinesio taping but will follow the same exercise protocol as the Kinesio Taping + Exercise Group. Participants will perform an exercise program prescribed three days a week, including isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions. Receives: Other: Convansionel Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Maximum mouth opening, protrusion, and lateral movements are jaw motions. Maximum mouth opening is determined by asking the patient to open their mouth as wide as possible and measuring the distance between the maxillary and mandibular incisors.
Measured: From enrollment to the end of treatment at 2 weeks
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported screening and assessment test that provides detailed information on sleep quality, as well as the type and severity of sleep disturbances over the past month. The form consists of 24 questions, from which scores for seven components are obtained: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Of the 24 questions, 19 are self-reported questions. The final five questions, which are answered by the bed partner or roommate, are not included in the scoring and are used only for clinical information. The self-reported questions cover various factors related to sleep quality, including estimates of sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items included in the scoring are grouped into seven component scores. Some components are represented by a single item, while
Measured: From enrollment to the end of treatment at 2 weeks
Beck Depression Inventory
The Beck Depression Inventory (BDI) was developed by Beck, Rush, Shaw, and Emery in 1978 with the aim of measuring somatic, emotional, cognitive, and motivational symptoms commonly observed in depression. The BDI consists of 21 items, each of which has four response options. Each item is scored on a scale from 0 to 3. By summing these scores, a total depression score is obtained. The maximum possible score is 63, with a higher total score indicating a higher level or severity of depression.
Measured: From enrollment to the end of treatment at 2 weeks
Joint Position Sense
The Cervical Joint Position Error Test is used to evaluate cervicocephalic proprioception and neck position sense. This test assesses the ability of the individual to return their head to the original neutral position after maximal rotation in the transverse and sagittal planes. Various devices such as laser pointers, electromagnetic devices, ultrasound-based devices, and electrogoniometers can be used to measure joint position sense error. Among these, using a laser pointer is more practical and easier compared to other methods and is frequently used.
Measured: From enrollment to the end of treatment at 2 weeks
Visual Analogue Scale
The Visual Analog Scale (VAS) consists of a pain level marked by the individual on a plane with a vertical line indicating the pain they are currently experiencing. The pain is rated as 0: no pain at all to 10: the most severe pain imaginable; Scoring is based on measuring the vertical mark made by the participant on the plane using a ruler.
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start26 Aug 2023
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinesiology TapingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, burak menek, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611358
- Sponsor's protocol ID
- E-10840098-772.02-4024
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinesio Taping and Exercise Interventions on Pain, Proprioception, Sleep, and Psychological Status in Individuals With Bruxism
- ClinicalTrials.gov ID
- NCT06611358
- Acronym / sponsor ID
- E-10840098-772.02-4024
- Conditions
- Kinesiology Taping, Bruxism, Exercise
- Keywords
- kinesiology taping, Bruxism, exercise, temporamandibular disfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 26 Aug 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 24 Sep 2024 (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 the unconscious act of grinding or clenching the teeth. It leads to hyperactivity of the masticatory muscles due to non-functional mandibular movements, which can result in pain symptoms and is, therefore, a significant factor contributing to changes in the temporomandibular joint. While the beneficial effects of exercise and kinesio taping on temporomandibular dysfunction and bruxism have been validated by various studies in the literature, research investigating their impact on cervical awareness remains quite limited. Hence, the aim of this study is to examine the effects of kinesio taping in addition to exercise on pain, mandibular range of motion, sleep quality, depression levels, and cervical awareness in individuals with bruxism.
Detailed description
Bruxism is a parafunctional or unconscious act of grinding or clenching the teeth. The factors contributing to bruxism are thought to include joint and soft tissue injuries, genetic factors, fatigue, and stress. There is a consensus that the etiology of bruxism is multifactorial and originates from central mechanisms. Bruxism is a common parafunctional activity in the general population, occurring both during sleep and while awake. Daytime bruxism, which is more prevalent in women, affects approximately 20% of the adult population, while sleep bruxism affects around 10%. Overall, the prevalence of bruxism decreases with age, regardless of gender.
The treatment of bruxism aims to raise awareness of oral parafunctional behaviors, alleviate pain, establish a resting position for the temporomandibular joint, improve posture in the head and neck regions, restore muscle strength between affected muscles, and achieve pain-free range of motion. While there is no definitive treatment method, a variety of invasive (acupuncture, injections, surgery, etc.) and non-invasive (exercise, electrical stimulation, manual trigger point stimulation, taping, etc.) approaches are employed. In recent years, reversible non-invasive approaches have gained importance in treatment.
Taping and bandaging have long been part of physiotherapy practices as treatment methods. Kinesio® Tape is a latex-free, thin, cotton-based tape. Developed in Japan 25 years ago, Kinesio® Tape has become widely used in recent years, not only in the United States, Europe, and many other parts of the world but also in our country. The structure, thickness, and weight of the tape are similar to the physical properties of the skin, with a high degree of longitudinal elasticity. The tension levels of the tapes vary depending on the treatment purpose. The primary goal of the Kinesio taping method is to support healing by allowing pain-free movement. In the Kinesio taping method, the tape is applied around or over the muscles as needed to prevent muscle overactivity.
Psychological counseling and exercise are widely used techniques in the treatment of temporomandibular dysfunction (TMD) and have been shown to have positive outcomes in the literature. In a randomized controlled trial by Nimela et al., the efficacy of counseling and masticatory muscle exercises alone was found to be similar to that of stabilization splints in both pain relief and increasing active maximal mouth opening. In a study by Coşkun et al., the addition of kinesio taping to counseling and exercises resulted in significantly greater benefits in both the short and long term. While the beneficial effects of exercise and kinesio taping on TMD and bruxism have been confirmed in various studies, research investigating their impact on cervical awareness is quite limited. Therefore, the aim of this study is to examine the effects of kinesio taping, in addition to exercise, on pain, temporomandibular joint range of motion, sleep quality, depression levels, and cervical awareness in individuals with bruxism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiology Taping Group | Experimental | Other: Kinesiology Taping and ExerciseIndividuals meeting the inclusion criteria will have kinesio tape applied to the temporomandibular joint by a physiotherapist every three days for a duration of two weeks. In addition to the kinesio taping, participants will perform an at-home exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions. |
| Conventional Group | Active comparator | Other: Convansionel ExerciseIndividuals meeting the inclusion criteria will not receive kinesio taping but will follow the same exercise protocol as the Kinesio Taping + Exercise Group. Participants will perform an exercise program prescribed three days a week, including isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). As part of the treatment protocol, each movement will be performed in 3 sets of 15 repetitions. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of teeth clenching complaints
- Being between the ages of 20 and 50
- No history of major trauma to the Temporamandibular region
- No history of surgical operations on the temporomandibular joint
Key exclusion criteria (4 listed)
- Individuals with conditions that can cause facial pain, such as sinusitis or trigeminal neuralgia
- Individuals with temporomandibular joint involvement secondary to inflammatory diseases
- Individuals with degenerative problems that restrict neck movements
- Individuals who have received treatment for bruxism in the last 6 months
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 |
|---|---|---|
| Kinesiology Taping and ExerciseIndividuals meeting the inclusion criteria will receive kinesio taping applied to the temporomandibular joint by a physiotherapist every three days for two weeks. The kinesio tape will be applied along the origin-insertion line with zero tension. In addition to the kinesio taping, participants will follow a exercise program prescribed three days a week. This program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol | Other | Kinesiology Taping Group |
| Convansionel ExerciseThis program will include isometric neck exercises (cervical flexion, extension, right and left lateral flexion, right and left rotation, and chin tuck exercises) and temporomandibular joint range of motion exercises (protrusion, retrusion, right and left lateral movement, and mouth opening-closing exercises). Each movement will be performed as 3 sets of 15 repetitions as part of the treatment protocol. | Other | Conventional Group |
Primary outcome
Range of Motion
Time frame: From enrollment to the end of treatment at 2 weeks
Maximum mouth opening, protrusion, and lateral movements are jaw motions. Maximum mouth opening is determined by asking the patient to open their mouth as wide as possible and measuring the distance between the maxillary and mandibular incisors.
Pittsburgh Sleep Quality Index
Time frame: From enrollment to the end of treatment at 2 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported screening and assessment test that provides detailed information on sleep quality, as well as the type and severity of sleep disturbances over the past month. The form consists of 24 questions, from which scores for seven components are obtained: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Of the 24 questions, 19 are self-reported questions. The final five questions, which are answered by the bed partner or roommate, are not included in the scoring and are used only for clinical information. The self-reported questions cover various factors related to sleep quality, including estimates of sleep duration, sleep latency, and the frequency and severity of specific sleep-related problems. The 18 items included in the scoring are grouped into seven component scores. Some components are represented by a single item, while
Beck Depression Inventory
Time frame: From enrollment to the end of treatment at 2 weeks
The Beck Depression Inventory (BDI) was developed by Beck, Rush, Shaw, and Emery in 1978 with the aim of measuring somatic, emotional, cognitive, and motivational symptoms commonly observed in depression. The BDI consists of 21 items, each of which has four response options. Each item is scored on a scale from 0 to 3. By summing these scores, a total depression score is obtained. The maximum possible score is 63, with a higher total score indicating a higher level or severity of depression.
Joint Position Sense
Time frame: From enrollment to the end of treatment at 2 weeks
The Cervical Joint Position Error Test is used to evaluate cervicocephalic proprioception and neck position sense. This test assesses the ability of the individual to return their head to the original neutral position after maximal rotation in the transverse and sagittal planes. Various devices such as laser pointers, electromagnetic devices, ultrasound-based devices, and electrogoniometers can be used to measure joint position sense error. Among these, using a laser pointer is more practical and easier compared to other methods and is frequently used.
Visual Analogue Scale
Time frame: From enrollment to the end of treatment at 2 weeks
The Visual Analog Scale (VAS) consists of a pain level marked by the individual on a plane with a vertical line indicating the pain they are currently experiencing. The pain is rated as 0: no pain at all to 10: the most severe pain imaginable; Scoring is based on measuring the vertical mark made by the participant on the plane using a ruler.
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiology Taping and Exercise and Convansionel Exercise in people with Kinesiology Taping and Bruxism, run by Istanbul Medipol University Hospital at 2 sites 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 4 inclusion and 4 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 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Range of Motion (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 5 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 11 Mar 2025.