Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance (LucoHybrid)

February 16, 2021 updated by: Dr. Ken Luco, Luco Hybrid OSA Appliance Inc.

The Treatment of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 0C3
        • Dr. K. Luco Dentistry Professional Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Started
Intervention: Treatment with the Luco Hybrid OSA Appliance (LHOA) Group 1, fitted with LHOA Group 2: LHOA removed for 48 hours
Device: The Luco Hybrid OSA Appliance
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
Active Comparator: Completed
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
Device: The Luco Hybrid OSA Appliance
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luco Hybrid OSA Appliance Inc.

Investigators

  • Principal Investigator: Ken J Luco, DDS, BSc, Luco Hybrid OSA Appliance Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 21, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lucohybridosa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information identifier: Study Protocol
  2. Statistical Analysis Plan
    Information identifier: Statistical Analysis Plan
  3. Informed Consent Form
    Information identifier: Informed Consent
  4. Clinical Study Report
    Information identifier: Study Report

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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