NCT06232993

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

October 13, 2023

Last Update Submit

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

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

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.

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.

Other: Exercises

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 splint

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.

kinesio taping

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.

exercises

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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)

Location

MeSH Terms

Conditions

Bruxism

Interventions

Exercise

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kamile N Tozar

    Adıyaman U

    PRINCIPAL INVESTIGATOR

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

Locations