Migraine Headache Clinical Trial
— LucoHybridOfficial title:
The Treatment of Sleep Bruxism With the Luco Hybrid OSA Appliance
NCT number | NCT02882880 |
Other study ID # | Lucohybridosa |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | July 2016 |
Verified date | February 2021 |
Source | Luco Hybrid OSA Appliance Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | July 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Dr. K. Luco Dentistry Professional Corporation | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Luco Hybrid OSA Appliance Inc. |
Canada,
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Carra MC, Huynh NT, El-Khatib H, Remise C, Lavigne GJ. Sleep bruxism, snoring, and headaches in adolescents: short-term effects of a mandibular advancement appliance. Sleep Med. 2013 Jul;14(7):656-61. doi: 10.1016/j.sleep.2013.03.009. Epub 2013 May 2. — View Citation
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Gomes CA, El Hage Y, Amaral AP, Politti F, Biasotto-Gonzalez DA. Effects of massage therapy and occlusal splint therapy on electromyographic activity and the intensity of signs and symptoms in individuals with temporomandibular disorder and sleep bruxism: — View Citation
Gomes CAFP, El-Hage Y, Amaral AP, Herpich CM, Politti F, Kalil-Bussadori S, Gonzalez TO, Biasotto-Gonzalez DA. Effects of Massage Therapy and Occlusal Splint Usage on Quality of Life and Pain in Individuals with Sleep Bruxism: A Randomized Controlled Trial. J Jpn Phys Ther Assoc. 2015;18(1):1-6. doi: 10.1298/jjpta.Vol18_001. — View Citation
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Hasegawa Y, Lavigne G, Rompré P, Kato T, Urade M, Huynh N. Is there a first night effect on sleep bruxism? A sleep laboratory study. J Clin Sleep Med. 2013 Nov 15;9(11):1139-45. doi: 10.5664/jcsm.3152. — View Citation
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Huang H, Song YH, Wang JJ, Guo Q, Liu WC. Excitability of the central masticatory pathways in patients with sleep bruxism. Neurosci Lett. 2014 Jan 13;558:82-6. doi: 10.1016/j.neulet.2013.11.014. Epub 2013 Nov 20. — View Citation
Huynh N, Lavigne GJ, Lanfranchi PA, Montplaisir JY, de Champlain J. The effect of 2 sympatholytic medications--propranolol and clonidine--on sleep bruxism: experimental randomized controlled studies. Sleep. 2006 Mar;29(3):307-16. — View Citation
Huynh NT, Rompré PH, Montplaisir JY, Manzini C, Okura K, Lavigne GJ. Comparison of various treatments for sleep bruxism using determinants of number needed to treat and effect size. Int J Prosthodont. 2006 Sep-Oct;19(5):435-41. Review. — View Citation
Karakis D, Dogan A, Bek B. Evaluation of the effect of two different occlusal splints on maximum occlusal force in patients with sleep bruxism: a pilot study. J Adv Prosthodont. 2014 Apr;6(2):103-8. doi: 10.4047/jap.2014.6.2.103. Epub 2014 Apr 22. — View Citation
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. Review. — View Citation
Klasser GD, Rei N, Lavigne GJ. Sleep bruxism etiology: the evolution of a changing paradigm. J Can Dent Assoc. 2015;81:f2. Review. — View Citation
Kostrzewa-Janicka J, Jurkowski P, Zycinska K, Przybylowska D, Mierzwinska-Nastalska E. Sleep-Related Breathing Disorders and Bruxism. Adv Exp Med Biol. 2015;873:9-14. doi: 10.1007/5584_2015_151. Review. — View Citation
Landry ML, Rompré PH, Manzini C, Guitard F, de Grandmont P, Lavigne GJ. Reduction of sleep bruxism using a mandibular advancement device: an experimental controlled study. Int J Prosthodont. 2006 Nov-Dec;19(6):549-56. — View Citation
Landry-Schönbeck A, de Grandmont P, Rompré PH, Lavigne GJ. Effect of an adjustable mandibular advancement appliance on sleep bruxism: a crossover sleep laboratory study. Int J Prosthodont. 2009 May-Jun;22(3):251-9. — View Citation
Lavigne G, Kato T. Usual and unusual orofacial motor activities associated with tooth wear. Int J Prosthodont. 2005 Jul-Aug;18(4):291-2. — View Citation
Lavigne G, Palla S. Transient morning headache: recognizing the role of sleep bruxism and sleep-disordered breathing. J Am Dent Assoc. 2010 Mar;141(3):297-9. — View Citation
Lin XL, Tang SY. Sodium valproate may be a treatment for sleep bruxism. J Child Adolesc Psychopharmacol. 2013 Nov;23(9):636-7. doi: 10.1089/cap.2013.0015. Epub 2013 Oct 29. — View Citation
Mainieri VC, Saueressig AC, Fagondes SC, Teixeira ER, Rehm DD, Grossi ML. Analysis of the effects of a mandibular advancement device on sleep bruxism using polysomnography, the BiteStrip, the sleep assessment questionnaire, and occlusal force. Int J Prost — View Citation
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Mayer P, Heinzer R, Lavigne G. Sleep Bruxism in Respiratory Medicine Practice. Chest. 2016 Jan;149(1):262-71. doi: 10.1378/chest.15-0822. Epub 2016 Jan 6. Review. — View Citation
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Okura K, Shigemoto S, Suzuki Y, Noguchi N, Omoto K, Abe S, Matsuka Y. Mandibular movement during sleep bruxism associated with current tooth attrition. J Prosthodont Res. 2017 Jan;61(1):87-95. doi: 10.1016/j.jpor.2016.06.003. Epub 2016 Jun 25. — View Citation
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Raphael KG, Sirois DA, Janal MN, Wigren PE, Dubrovsky B, Nemelivsky LV, Klausner JJ, Krieger AC, Lavigne GJ. Sleep bruxism and myofascial temporomandibular disorders: a laboratory-based polysomnographic investigation. J Am Dent Assoc. 2012 Nov;143(11):122 — View Citation
Saito M, Yamaguchi T, Mikami S, Watanabe K, Gotouda A, Okada K, Hishikawa R, Shibuya E, Lavigne G. Temporal association between sleep apnea-hypopnea and sleep bruxism events. J Sleep Res. 2013 Nov 4. doi: 10.1111/jsr.12099. [Epub ahead of print] — View Citation
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* Note: There are 55 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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