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

Sponsor

Hasan Kalyoncu University (Other)

Overall Status

Completed

CT.gov ID

NCT05323942

Collaborator

(none)

Enrollment

Location

Arm

15.7

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Bruxism, Childhood	Other: Education and Exercise Therapy Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 8, 2020

Actual Primary Completion Date :

Apr 16, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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.	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.

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.

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.

Outcome Measures

Primary Outcome Measures

Change from Baseline in Pain at 8 weeks [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.
Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 8 weeks [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.
Change from Baseline in Oral Habits at 8 weeks [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.

Secondary Outcome Measures

Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 8 weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.