The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism

Sleep Bruxism, Childhood Clinical Trial

Official title:

The Effect of Sleep Hygiene and Exercise Therapy on Bruxism, Sleep Habits, and Oral Habits in Children With Sleep Bruxism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323942
• Other study ID #: 2019/92
• Status: Completed
• Phase: N/A
• Start date: March 8, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2021
• Source: Hasan Kalyoncu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism
• Sleep Bruxism, Childhood

Intervention

Other:
• Education and Exercise Therapy Group
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.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 8 weeks
Primary	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.	Baseline, 8 weeks
Primary	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.	Baseline, 8 weeks
Secondary	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.	Baseline, 8 weeks