Management of Myofascial Pain in Children With Sleep Bruxism
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
1 other identifier
interventional
57
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2023
CompletedFirst Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedJanuary 31, 2024
January 1, 2024
4 months
October 13, 2023
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Applied before, 1 week after, and 5 weeks after the treatment
Study Arms (3)
occlusal splint
EXPERIMENTALA 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
EXPERIMENTALThe 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
EXPERIMENTALParticipants in the EG group performed the exercises twice a day, with 10 repetitions and 3 sets for 5 weeks.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adiyaman Universty
Adıyaman, 02000, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamile N Tozar
Adıyaman U
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
October 13, 2023
First Posted
January 31, 2024
Study Start
December 1, 2022
Primary Completion
April 10, 2023
Study Completion
April 10, 2023
Last Updated
January 31, 2024
Record last verified: 2024-01