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To determine the effectiveness of the Luco Hybrid OSA Appliance in the treatment of sleep bruxism and to aid in the treatment of associated tension/migraine type headaches in adults.
51 subjects were selected and separated into two groups: those new to the treatment (Group 1)and those who had been in treatment for more than 1 year (Group 2). There were 32 participants in group 1 and 19 in group 2. mean age for Group 1 was 41.7 and Group 2 was 50.5. The age range for Group 1 was 21 to 66 and in Group 2 34 to 73.
Group 1 subjects were fitted with a Luco hybrid OSA appliance (LHOA). They were followed over a 14 day period with adjustments made to the device as required. The second study [milestone] was completed at that time.
Group 2 subjects, who had previously been in treatment with the device for and mean of 4.1 years, had an initial study with the device and a second study following 48 hours without the device.
Both groups were studied again at 60 days and results compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Started | Other | Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours |
|
| Completed | Active Comparator | Intervention: The LUco Hybrid OSA APpliance The subjects that actually completed the study in both groups. Group 1 n = 32, in Group 2 n=19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Luco Hybrid OSA Appliance | Device | Group 1, initial treatment with the device, reassessed at 14 and 60 days, Group 2, removal of the treatment for 48 hours, to determine if relapse occurs, retested at 60 days with the device (recovery from intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Response to treatment with the Luco Hybrid OSA Appliance | Clinical examination, sleep study and visual analog scale. Clinical examination of the subject's musculature, temporomandibular joints (TMJ), and measurement of the range of mandibular movements. The home sleep study (HSS) measured the number and duration of sleep bruxism events as well as the heart rate associated with these events. The visual analog scale (VAS) recorded the patient's response regarding TMJ pain on waking and later in the day, jaw muscle pain on waking and later in the day, tooth sensitivity to temperature extremes, tension/migraine type headaches on waking and later in the day and neck/shoulder pain on waking and later in the day. HSS scoring according to the American Academy of Sleep Medicine's "Manual for the Scoring of Sleep and Associated Events" for sleep bruxism. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken J Luco, DDS, BSc | Luco Hybrid OSA Appliance Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. K. Luco Dentistry Professional Corporation | Kingston | Ontario | K7L 0C3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20859563 | Background | Klasser GD, Greene CS, Lavigne GJ. Oral appliances and the management of sleep bruxism in adults: a century of clinical applications and search for mechanisms. Int J Prosthodont. 2010 Sep-Oct;23(5):453-62. | |
| 27283599 | Background | Raphael KG, Santiago V, Lobbezoo F. Is bruxism a disorder or a behaviour? Rethinking the international consensus on defining and grading of bruxism. J Oral Rehabil. 2016 Oct;43(10):791-8. doi: 10.1111/joor.12413. Epub 2016 Jun 10. |
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| ID | Term |
|---|---|
| D020186 | Sleep Bruxism |
| D018781 | Tension-Type Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D002012 | Bruxism |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D020447 | Parasomnias |
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|
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |