BruxismNCT06232993
Management of Myofascial Pain in Children With Sleep Bruxism
A study testing Kinesio taping, Occlusal Splinting and Exercises in people with Bruxism, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
This study compared the effectiveness of Kinesio tape and occlusal splint application in improving sleep quality and reducing myofascial pain in children with sleep bruxism. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruxism
- What is being tested?
- Kinesio taping, Occlusal Splinting and Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 10 Apr 2023
- 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-11 years [1] presented to the clinic and had at least one symptom of sleep bruxism,
- Children and parents who agreed to participate in the study,
- Children who have not been treated for sleep bruxism before,
- Children who can cooperate,
- Children without maxillofacial trauma.
Who cannot join
- • Children with psychiatric/neurological/systemic disorders,
- Children with a history of allergies or asthma,
- Children using orthodontic appliances,
- Children taking any medication,
- Children with dental abscess or fistula mouth,
- Children using a fixed or removable placeholder appliance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Effects of Kinesio Tape and Occlusal Splint Use in the Management of Myofascial Pain in Children With Sleep Bruxism: A Randomized Controlled Trial
This study compared the effectiveness of Kinesio tape and occlusal splint application in improving sleep quality and reducing myofascial pain in children with sleep bruxism.
Read the detailed description
Forty-seven pediatric patients with sleep bruxism symptoms were randomly assigned into 3 groups for treatment: Kinesio tape group (KT), Occlusal splint group (OS), and Exercise group (EG). The following assessments were made in all 3 groups, before the treatment and at the end of the 1st and 5th week: Wong-Baker Faces Pain Scale (WBFPS), measurement of maximum mouth opening, assessment of pressure pain threshold of the bilateral masseter and temporal muscles, and evaluation of temporal and masseter muscle thickness by ultrasonography.
- Conditions
- Bruxism
- Being tested
- Kinesio taping, Occlusal Splinting, Exercises
- Medical subject headings
- Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingOther
Kinesio taping is a technique that involves the application of a special elastic tape to the skin to provide support to muscles and joints without restricting the body's range of motion. This method is designed to facilitate the body's natural healing process and improve muscle function while providing support and stability to muscles and joints. Kinesio tape is believed to help reduce pain, support muscles during movement, and aid in rehabilitation. It is commonly used in sports medicine and physical therapy to address a variety of musculoskeletal conditions and injuries.
Occlusal SplintingOther
Occlusal splinting, also known as a bite guard or night guard, is a removable dental appliance typically made of plastic that is custom-fitted to a patient's upper or lower teeth. It is primarily used to address issues related to teeth grinding (bruxism) or temporomandibular joint (TMJ) disorders. The splint is designed to fit over the teeth, creating a barrier between the upper and lower teeth to prevent grinding and clenching during sleep. Occlusal splints aim to reduce the impact of bruxism on the teeth and jaw, alleviate associated pain, protect the teeth from wear, and promote relaxation of the jaw muscles.
ExercisesOther
For patients with bruxism, exercises can be beneficial in managing symptoms and promoting relaxation of the jaw muscles. These exercises aim to reduce the frequency and intensity of bruxism, alleviate associated pain, and improve overall jaw function and comfort. It's important for patients to consult with healthcare professionals to determine the most appropriate exercises for their individual needs.
| Study group | Role | What they receive |
|---|---|---|
| occlusal splint | Experimental | A 0.5 mm thick hard thermoplastic acrylic plate was adapted to the model in the laboratory and prepared to cover the occlusal, buccal, and lingual surfaces of the teeth Receives: Other: Kinesio taping |
| kinesio taping | Experimental | The tape was cut into 2 pieces of an 'I' shape, approximately 5 cm long and 2.5 cm wide, according to the instructions in the manual. Receives: Other: Occlusal Splinting |
| exercises | Experimental | Participants in the EG group performed the exercises twice a day, with 10 repetitions and 3 sets for 5 weeks. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Faces Pain Scale
The Wong-Baker Faces Pain Scale is a pain assessment tool that uses a series of faces to help individuals, especially children, express the intensity of their pain. It consists of a line of faces ranging from a smiling face (indicating "no pain") to a face with a distressed expression (indicating "worst pain"). The person is asked to point to the face that best represents their level of pain, allowing healthcare providers to assess and understand the individual's pain experience, particularly in cases where verbal communication may be challenging.
Measured: Applied before, 1 week after, and 5 weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Dec 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
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.
- 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
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamile Nur Tozar, Adiyaman University
- Investigators
- Kamile N Tozar, Principal investigator, Adıyaman U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232993
- Sponsor's protocol ID
- Decision number:2022-4-2
- Status last verified
- Jan 2024
- First submitted
- 13 Oct 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Effects of Kinesio Tape and Occlusal Splint Use in the Management of Myofascial Pain in Children With Sleep Bruxism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06232993
- Acronym / sponsor ID
- Decision number:2022-4-2
- Conditions
- Bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 31 Jan 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.
This study compared the effectiveness of Kinesio tape and occlusal splint application in improving sleep quality and reducing myofascial pain in children with sleep bruxism.
Detailed description
Forty-seven pediatric patients with sleep bruxism symptoms were randomly assigned into 3 groups for treatment: Kinesio tape group (KT), Occlusal splint group (OS), and Exercise group (EG). The following assessments were made in all 3 groups, before the treatment and at the end of the 1st and 5th week: Wong-Baker Faces Pain Scale (WBFPS), measurement of maximum mouth opening, assessment of pressure pain threshold of the bilateral masseter and temporal muscles, and evaluation of temporal and masseter muscle thickness by ultrasonography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| occlusal splint | Experimental | Other: Kinesio tapingA 0.5 mm thick hard thermoplastic acrylic plate was adapted to the model in the laboratory and prepared to cover the occlusal, buccal, and lingual surfaces of the teeth |
| kinesio taping | Experimental | Other: Occlusal SplintingThe tape was cut into 2 pieces of an 'I' shape, approximately 5 cm long and 2.5 cm wide, according to the instructions in the manual. |
| exercises | Experimental | Other: ExercisesParticipants in the EG group performed the exercises twice a day, with 10 repetitions and 3 sets for 5 weeks. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 6-11 years [1] presented to the clinic and had at least one symptom of sleep bruxism,
- Children and parents who agreed to participate in the study,
- Children who have not been treated for sleep bruxism before,
- Children who can cooperate,
- Children without maxillofacial trauma.
Key exclusion criteria (6 listed)
- • Children with psychiatric/neurological/systemic disorders,
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 |
|---|---|---|
| Kinesio tapingKinesio taping is a technique that involves the application of a special elastic tape to the skin to provide support to muscles and joints without restricting the body's range of motion. This method is designed to facilitate the body's natural healing process and improve muscle function while providing support and stability to muscles and joints. Kinesio tape is believed to help reduce pain, support muscles during movement, and aid in rehabilitation. It is commonly used in sports medicine and physical therapy to address a variety of musculoskeletal conditions and injuries. | Other | occlusal splint |
| Occlusal SplintingOcclusal splinting, also known as a bite guard or night guard, is a removable dental appliance typically made of plastic that is custom-fitted to a patient's upper or lower teeth. It is primarily used to address issues related to teeth grinding (bruxism) or temporomandibular joint (TMJ) disorders. The splint is designed to fit over the teeth, creating a barrier between the upper and lower teeth to prevent grinding and clenching during sleep. Occlusal splints aim to reduce the impact of bruxism on the teeth and jaw, alleviate associated pain, protect the teeth from wear, and promote relaxation of the jaw muscles. | Other | kinesio taping |
| ExercisesFor patients with bruxism, exercises can be beneficial in managing symptoms and promoting relaxation of the jaw muscles. These exercises aim to reduce the frequency and intensity of bruxism, alleviate associated pain, and improve overall jaw function and comfort. It's important for patients to consult with healthcare professionals to determine the most appropriate exercises for their individual needs. | Other | exercises |
Primary outcome
Wong-Baker Faces Pain Scale
Time frame: Applied before, 1 week after, and 5 weeks after the treatment
The Wong-Baker Faces Pain Scale is a pain assessment tool that uses a series of faces to help individuals, especially children, express the intensity of their pain. It consists of a line of faces ranging from a smiling face (indicating "no pain") to a face with a distressed expression (indicating "worst pain"). The person is asked to point to the face that best represents their level of pain, allowing healthcare providers to assess and understand the individual's pain experience, particularly in cases where verbal communication may be challenging.
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 31 Jan 2024.
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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.
Kamile N Tozar principal investigator
Adıyaman U
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping, Occlusal Splinting and Exercises in people with Bruxism, run by Adiyaman 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 5 inclusion and 6 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 31 Jan 2024. 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?
Wong-Baker Faces Pain Scale (time frame: Applied before, 1 week after, and 5 weeks after the treatment). 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 31 Jan 2024.