In late 2015 and early 2016,we conducted an in-office sleep study of patients who had been referred to the office for management of their TMD or facial pain as well as regular patients in the practice. Each patient was screened for sleep apnea, UARS and snoring and those who suffer from these conditions were excluded. The following data represents the results of before and after treatment with the Luco Hybrid OSA Appliance:
A total of 30 patients eventually met the inclusion criteria for the study (the requirements to be considered). There were 10 men and 20 women in the study. The following table lists the demographic breakdown.
The American Academy of Sleep Medicine’s (AASM) publication “The International Classification of Sleep Disorders”, Volume 3 has classified sleep bruxism as a movement-type sleep disorder. The World Health Organization (WHO) publish a comprehensive coding of every possible disease. Sleep bruxism has been assigned the ICD-10 (10th edition of the WHO classification) of G47.63. It should be noted that awake bruxism is excluded from this code. awake bruxism is considered psychogenic and is assigned the code F45.8, whcih excludes sleep bruxism. They are not the same disease and both have different causes. The AASM classification of sleep bruxism clearly shows this to be a true sleep disorder as it occurs 80% of the time with obstructive apnea events. This study was conducted on the 20% not associated with sleep apnea.
The factors considered in the study were based upon the AASM classification as the current literature on sleep bruxism including:
- The number, type and duration of sleep bruxism events
- The health of the musculature, TMJ (jaw joints), dentition (teeth and supporting structures)
- The maximum pulse rate associated with sleep bruxism
- The range of motion of the mandible
- The effect this treatment has on the patient’s quality of life including:
- TMJ pain on waking
- Jaw muscle pain on waking and later in the day
- Tooth hypersensitivity to thermal (hot and cold)
- Headaches on waking and later in the day
All of these factors have been directly attributed to sleep bruxism. To record this information, specialist equipment was needed. Two 12 channel home sleep recorders were used (Medibyte Event) that recorded breathing effort, heart rate, blood oxygen levels, upper airway resistance (UARS), body position, and muscle contractions in the masseter and temporalis muscles (bruxism events). Analysis of the data obtained before and after treatment with the Luco Hybrid OSA Appliance was completed and analyzed using GraphPad 6.07 for statistical significance. Clinical examination of the muscles, TMJ and range of motion were conducted before and after treatment. A visual analog scale was used to assess how the patient’s perception of their improvement changed (quality of life assessment).
The following tables outline the results obtained. A discussion follows.
Sleep Bruxism occurs in three forms: Tonic or sustained clenching, phasic or rhythmic contractions, or mixed, which is a combination of both types. All three types were separated, scored and analyses. The following table shows the analysis on the mean or averaged results from the 30 patients:
Tonic Sleep Bruxism
Phasic Sleep Bruxism
Mixed Sleep Bruxism
As can be seen in the above tables, all three types of sleep bruxism were significantly reduces after treatment with the Luco Hybrid OSA Appliance.
The AASM classification indicates that sleep bruxism is chemically mediated. This sympathetic stimulation of the body results in an increase of both the pulse rate and the blood pressure transiently during the sleep bruxism events. This was observed in this study. The following table represents the data collected on the maximum heart rate during bruxism events:
Of note, 17 of the subject’s heart rates exceeded 100 beats per minute (bpm). This is considered tachycardia or racing of the heart. During tachycardia, the heart does not pump blood efficiently as the left (largest) ventricle does not have enough time to re-fill. In all subjects, the heart rate was reduced below 100 bpm.
With sleep apnea, a commonly used measurement is the AHI or apnea hypopnea index. It represents the number of apnea events occuring per hour of sleep. With sleep bruxism, the bruxism index is used. It represents the number of bruxism events or bursts occuring per hour of sleep. The following table represents the data collected on the bruxism index:
As can be seen in the above table, the bruxism index was significantly reduced following treatment with the Luco Hybrid OSA Appliance.
Using GraphPad 6, a tow tailed t test was used on the mean values of these tables. The following table shows this analysis. A p value of <5 was used.
TMJ Pain is a common complaint of sufferers of sleep bruxism. Examination of the TMJ was conducted before and after treatment. The following table represents the data collected:
The following table represents the GraphPad analysis of this data for the TMJ:
As can be seen in the analysis, TMJ pain (both lateral pole (outsides) and posterior joint space (nerves behind the bone) demonstrated a significant reduction in pain.
Assessing quality of life changes is critical in every study of a treatment modality. Visual analog scales or VAS scales are commonly used in research as this allows the patient to input their response to the treatment. The VAS scale used in this study assessed the 5 variables listed above. The following table shows the data for the VAS scale:
As can be seen above, there was a reduction in all 5 parameters of the VAS scale. The following table represents the GraghPad 6 analysis of this data:
The treatment of the 30 patients in the study provided a wealth of information. There was a significant improvement in all aspects measured relating to sleep bruxism. The VAS scale correlated very well with these findings as there was a significant improvement in all aspects of the VAS scale.
This study clearly demonstrates the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep bruxism. As sleep bruxism occurs in 8-24% of the population, there are a significant number of people suffering from the symptoms of sleep bruxism that need no to.