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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06232993
Other study ID # Decision number:2022-4-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date April 10, 2023

Study information

Verified date January 2024
Source Adiyaman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date April 10, 2023
Est. primary completion date April 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - • 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kinesio taping
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
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.
Exercises
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.

Locations

Country Name City State
Turkey Adiyaman Universty Adiyaman

Sponsors (1)

Lead Sponsor Collaborator
Adiyaman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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