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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2021
Source Luco Hybrid OSA Appliance Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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).

Locations

Country Name City State
Canada Dr. K. Luco Dentistry Professional Corporation Kingston Ontario

Sponsors (1)

Lead Sponsor Collaborator
Luco Hybrid OSA Appliance Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (55)

Abe S, Gagnon JF, Montplaisir JY, Postuma RB, Rompré PH, Huynh NT, Kato T, Kawano F, Lavigne GJ. Sleep bruxism and oromandibular myoclonus in rapid eye movement sleep behavior disorder: a preliminary report. Sleep Med. 2013 Oct;14(10):1024-30. doi: 10.101 — View Citation

Aqueveque P, Pino E, López R. Electrical stimulation device as possible treatment for nocturnal bruxism: preliminary results. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:3571-3. doi: 10.1109/EMBC.2013.6610314. — View Citation

Cahlin BJ, Hedner J, Dahlström L. A randomised, open-label, crossover study of the dopamine agonist, pramipexole, in patients with sleep bruxism. J Sleep Res. 2017 Feb;26(1):64-72. doi: 10.1111/jsr.12440. Epub 2016 Jul 17. — View Citation

Carra MC, Huynh N, Fleury B, Lavigne G. Overview on Sleep Bruxism for Sleep Medicine Clinicians. Sleep Med Clin. 2015 Sep;10(3):375-84, xvi. doi: 10.1016/j.jsmc.2015.05.005. Epub 2015 Jul 8. Review. — View Citation

Carra MC, Huynh N, Lavigne G. Sleep bruxism: a comprehensive overview for the dental clinician interested in sleep medicine. Dent Clin North Am. 2012 Apr;56(2):387-413. doi: 10.1016/j.cden.2012.01.003. Review. — View Citation

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

Castrillon EE, Ou KL, Wang K, Zhang J, Zhou X, Svensson P. Sleep bruxism: an updated review of an old problem. Acta Odontol Scand. 2016 Jul;74(5):328-34. doi: 10.3109/00016357.2015.1125943. Epub 2016 Jan 12. Review. — View Citation

Chate R. Summary of: Over-the-counter (OTC) bruxism splints available on the Internet. Br Dent J. 2014 Jun 13;216(11):642-3. doi: 10.1038/sj.bdj.2014.480. — View Citation

de-la-Hoz JL. Sleep bruxism: review and update for the restorative dentist. Alpha Omegan. 2013 Spring-Summer;106(1-2):23-8. Review. — View Citation

Dharmadhikari S, Romito LM, Dzemidzic M, Dydak U, Xu J, Bodkin CL, Manchanda S, Byrd KE. GABA and glutamate levels in occlusal splint-wearing males with possible bruxism. Arch Oral Biol. 2015 Jul;60(7):1021-9. doi: 10.1016/j.archoralbio.2015.03.006. Epub 2015 Mar 28. — View Citation

Dowd ET. Nocturnal bruxism and hypnotherapy: a case study. Int J Clin Exp Hypn. 2013;61(2):205-18. doi: 10.1080/00207144.2013.753832. — View Citation

Franco L, Rompre PH, de Grandmont P, Abe S, Lavigne GJ. A mandibular advancement appliance reduces pain and rhythmic masticatory muscle activity in patients with morning headache. J Orofac Pain. 2011 Summer;25(3):240-9. — View Citation

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

Gu W, Yang J, Zhang F, Yin X, Wei X, Wang C. Efficacy of biofeedback therapy via a mini wireless device on sleep bruxism contrasted with occlusal splint: a pilot study. J Biomed Res. 2015 Apr;29(2):160-8. doi: 10.7555/JBR.28.20130145. Epub 2014 Nov 18. — View Citation

Guaita M, Högl B. Current Treatments of Bruxism. Curr Treat Options Neurol. 2016 Feb;18(2):10. doi: 10.1007/s11940-016-0396-3. — View Citation

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

Hesselbacher S, Subramanian S, Rao S, Casturi L, Surani S. Self-reported sleep bruxism and nocturnal gastroesophageal reflux disease in patients with obstructive sleep apnea: relationship to gender and ethnicity. Open Respir Med J. 2014 Oct 22;8:34-40. doi: 10.2174/1874306401408010034. eCollection 2014. — View Citation

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

Malcmacher L. Are you prescribing bruxism appliances? Dent Today. 2014 Sep;33(9):126-9. — View Citation

Malcmacher L. Bruxism--Are You Helping or Hurting Your Patients? J N J Dent Assoc. 2015 Winter;86(1):14-6. — View Citation

Malcmacher L. Ensuring Restorative Success With Bruxism Testing. Dent Today. 2015 Jul;34(7):131-3. — View Citation

Matsumoto H, Tsukiyama Y, Kuwatsuru R, Koyano K. The effect of intermittent use of occlusal splint devices on sleep bruxism: a 4-week observation with a portable electromyographic recording device. J Oral Rehabil. 2015 Apr;42(4):251-8. doi: 10.1111/joor.1 — View Citation

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

Minakuchi H, Sogawa C, Miki H, Hara ES, Maekawa K, Sogawa N, Kitayama S, Matsuka Y, Clark GT, Kuboki T. Sleep bruxism frequency and platelet serotonin transporter activities in young adult subjects. Sleep Breath. 2016 Mar;20(1):271-6. doi: 10.1007/s11325- — View Citation

Miyawaki S, Lavigne GJ, Pierre M, Guitard F, Montplaisir JY, Kato T. Association between sleep bruxism, swallowing-related laryngeal movement, and sleep positions. Sleep. 2003 Jun 15;26(4):461-5. — View Citation

Nashed A, Lanfranchi P, Rompré P, Carra MC, Mayer P, Colombo R, Huynh N, Lavigne G. Sleep bruxism is associated with a rise in arterial blood pressure. Sleep. 2012 Apr 1;35(4):529-36. doi: 10.5665/sleep.1740. — View Citation

Ohmure H, Kanematsu-Hashimoto K, Nagayama K, Taguchi H, Ido A, Tominaga K, Arakawa T, Miyawaki S. Evaluation of a Proton Pump Inhibitor for Sleep Bruxism: A Randomized Clinical Trial. J Dent Res. 2016 Dec;95(13):1479-1486. Epub 2016 Jul 29. — View Citation

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

Porporatti AL, Costa YM, Conti PC, Bonjardim LR, Calderon Pdos S. Primary headaches interfere with the efficacy of temporomandibular disorders management. J Appl Oral Sci. 2015 Mar-Apr;23(2):129-34. doi: 10.1590/1678-775720130557. Epub 2014 Jul 4. — View Citation

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. — View Citation

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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Silber MH. Sleep-related movement disorders. Continuum (Minneap Minn). 2013 Feb;19(1 Sleep Disorders):170-84. doi: 10.1212/01.CON.0000427207.13553.68. Review. — View Citation

Sjoholm T, Kauko T, Kemppainen P, Rauhala E. Long-term use of occlusal appliance has impact on sleep structure. J Oral Rehabil. 2014 Nov;41(11):795-800. doi: 10.1111/joor.12201. Epub 2014 Jun 18. — View Citation

Solanki N, Singh BP, Chand P, Siddharth R, Arya D, Kumar L, Tripathi S, Jivanani H, Dubey A. Effect of mandibular advancement device on sleep bruxism score and sleep quality. J Prosthet Dent. 2017 Jan;117(1):67-72. doi: 10.1016/j.prosdent.2016.04.009. Epu — View Citation

Stark CD, Stark RJ. Sleep and chronic daily headache. Curr Pain Headache Rep. 2015 Jan;19(1):468. doi: 10.1007/s11916-014-0468-6. Review. — View Citation

Sumiya M, Mizumori T, Kobayashi Y, Inano S, Yatani H. Suppression of sleep bruxism: effect of electrical stimulation of the masseter muscle triggered by heart rate elevation. Int J Prosthodont. 2014 Jan-Feb;27(1):80-6. doi: 10.11607/ijp.3330. — View Citation

Tavares LM, da Silva Parente Macedo LC, Duarte CM, de Goffredo Filho GS, de Souza Tesch R. Cross-sectional study of anxiety symptoms and self-report of awake and sleep bruxism in female TMD patients. Cranio. 2016 Nov;34(6):378-381. Epub 2016 Apr 20. — View Citation

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Yamaguchi K, Ishiura Y, Tanaka S, Baba K. Influence of the rigidity of a provisional restoration supported on four immediately loaded implants in the edentulous maxilla on biomechanical bone-implant interactions under simulated bruxism conditions: a three — View Citation

Zhou WN, Fu HY, Du YF, Sun JH, Zhang JL, Wang C, Svensson P, Wang KL. Short-term effects of repetitive transcranial magnetic stimulation on sleep bruxism - a pilot study. Int J Oral Sci. 2016 Mar 30;8(1):61-5. doi: 10.1038/ijos.2015.35. — View Citation

* Note: There are 55 references in allClick here to view all references

Outcome

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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