Management of Myofascial Pain in Children With Sleep Bruxism

January 22, 2024 updated by: Kamile Nur Tozar, Adiyaman University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adıyaman, Turkey, 02000
        • Adiyaman Universty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: occlusal splint
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
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.
Experimental: kinesio taping
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.
Other: 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.
Experimental: exercises
Participants in the EG group performed the exercises twice a day, with 10 repetitions and 3 sets for 5 weeks.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Applied before, 1 week after, and 5 weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adiyaman University

Investigators

  • Principal Investigator: Kamile N Tozar, Adıyaman U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Decision number:2022-4-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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