The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
Primary Purpose
Sleep Bruxism, Childhood
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education and Exercise Therapy Group
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Bruxism, Childhood focused on measuring Bruxism, Sleep Habits, Oral Habits, Children
Eligibility Criteria
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.
Sites / Locations
- Hasan Kalyoncu University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Education and Exercise Therapy Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Change from Baseline in Pain at 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.
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 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.
Change from Baseline in Oral Habits at 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.
Secondary Outcome Measures
Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05323942
Brief Title
The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
Official Title
The Effect of Sleep Hygiene and Exercise Therapy on Bruxism, Sleep Habits, and Oral Habits in Children With Sleep Bruxism.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 8, 2020 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aims of this study were to determine the relationship between sleep bruxism, oral habits, and sleep habits and establish treatment approaches in children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism, Childhood
Keywords
Bruxism, Sleep Habits, Oral Habits, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education and Exercise Therapy Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Education and Exercise Therapy Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change from Baseline in Oral Habits at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 8 weeks
Description
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.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer, PhD
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27410
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism
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