- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05323942
The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
The Effect of Sleep Hygiene and Exercise Therapy on Bruxism, Sleep Habits, and Oral Habits in Children With Sleep Bruxism.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cross-sectional study was conducted on children aged between 6-and 13 years, diagnosed with sleep bruxism (SB). Initially, 82 children with a diagnosis of SB were evaluated. Among those, 37 children volunteered were followed for 8 weeks to investigate the effects of the education, sleep hygiene and therapeutic exercise program.
Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise.
Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise 5 times and 5 times a day for 8 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gaziantep, Turkey, 27410
- Hasan Kalyoncu University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between the ages of 6 - 13,
- Having a diagnosis of sleep bruxism,,
- And a parent signing informed consent for participation in the study.
Exclusion Criteria:
- Children who received orthodontic treatment,
- Children with the dentofacial anomaly, a history of TMJ surgery, having a medical history of neurological or psychiatric disease
- and those who could not cooperate were excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Education and Exercise Therapy Group
Children and their parents were trained about bruxism, parafunctional oral habits, and sleep hygiene education.
Therapeutic exercises about head-neck posture, breathing, and relaxation were given for 8 weeks.
|
82 children were evaluated. Among those, 37 volunteered children were trained and demonstrated in practice about bruxism, parafunctional oral habits, sleep hygiene education, and 5x5 therapeutic exercises. Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise with 5 set and 5 times a day for 8 weeks. Sleep hygiene education was given to parents and children with explanation of the parafunctional oral habits to raise awareness about being conscious about the oral habits. Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Pain at 8 weeks
Time Frame: Baseline, 8 weeks
|
The pain was measured with the Visual Analogue Scale (VAS) and the degree of pain was questioned in various situations. The children were told to mark the value of 0 when they felt no pain, 10 when they felt excruciating pain, and to mark the pain they felt within this range. And it was supported by facial expressions. Headache when waking up in the morning, jaw pain when waking up in the morning, jaw pain while eating, jaw pain after meals, and jaw pain before going to bed at night were questioned and each was measured by VAS. |
Baseline, 8 weeks
|
|
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 8 weeks
Time Frame: Baseline, 8 weeks
|
Children's Sleep Habits Questionnaire (CSHQ) investigate children's sleep habits and sleep-related problems, and its Turkish validity and reliability were used. After giving the necessary information about the questionnaire to the parents, they were asked to fill it out. The CSHQ has satisfactory psychometric properties in children and has been used in the investigation of sleep in children. The form consists of 33 items in total. There are eight subscales in the scale, which can be listed as bedtime resistance, delayed falling asleep, sleep duration, sleep anxiety, night awakenings, parasomnias, impaired breathing during sleep, and daytime sleepiness. |
Baseline, 8 weeks
|
|
Change from Baseline in Oral Habits at 8 weeks
Time Frame: Baseline, 8 weeks
|
The evaluation was made with the 21-item Oral Habits Questionnaire (OAA). Each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; filled with 1 = several times or 0 = none". A person's overall score can range from 0 to 84. A low overall score indicates positive oral habit, while a higher score indicates negative oral habit. After making sure that the questions were correctly understood by the children, the markings of the answers were made by the practitioner. |
Baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 8 weeks
Time Frame: Baseline, 8 weeks
|
TMJ ROM was analyzed as active and passive. Maximal mouth opening and right-left shifts were measured using a linear ruler. Active and passive maximal mouth opening, right and left lateral displacement, and protrusion of the TMJ were measured in millimeters (mm) based on reference points in the maxillary and mandibular anterior incisors. Crepitation and joint clicking sounds were questioned during mouth opening and closing, and normal line deviations were detected during mouth opening. |
Baseline, 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/92
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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