Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance

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.

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Key information

Conditions

Sleep Bruxism Brain Diseases Bruxism Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Mental Disorders Migraine Disorders Migraine Headache Nervous System Diseases Parasomnias Sleep Wake Disorders Stomatognathic Diseases Tension Headache Tension-Type Headache Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. K. Luco Dentistry Professional Corporation

Kingston, Ontario, K7L 0C3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age (adult)
capable of giving informed consent
met the AASM criteria for sleep bruxism
had sound dentition
did not have active obstructive sleep apnea(OSA)/upper airway resistance syndrome (UARS)

Exclusion criteria

younger than 18
incapable of informed consent
did not meet the AASM criteria for sleep bruxism
discovered OSA or UARS in the initial study
did not have sound dentition (active caries, periodontal disease, inadequate number of teeth
had obstructive sleep apnea/UARS
did not complete the study
completed the study but did not complete all aspects of the study

Treatment and study plan

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).

Other names: Mandibular advancement appliance

Primary outcomes

Response to treatment with the Luco Hybrid OSA Appliance

Time frame: 60 days

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.

Sponsors and collaborators

Lead sponsor

Luco Hybrid OSA Appliance Inc.

Industry

Registry information

Official study title

The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance

Acronym: LucoHybrid

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 30, 2016
Registry last updated: Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed