Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism

Sleep Bruxism Clinical Trial

Official title:

The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255878
• Other study ID #: 87284
• Status: Completed
• Phase: N/A
• First received: December 7, 2010
• Last updated: December 7, 2010
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Sleep bruxism (SB) is defined as a "stereotyped movement disorder characterized by grinding or clenching of the teeth during sleep" usually associated with sleep arousal. It might lead to abrasive tooth wear, hypermobility of teeth, tooth hypersensitivity, hypertrophy of the masticatory muscles and pain in the masticatory muscles.

Diagnostic procedures include clinical evaluation, ambulatory monitoring sleep laboratory investigations and others. The clinical approach comprises the patient's history, orofacial examination, and tooth wear classification.

There is no specific treatment for bruxism. Management of SB comprises psychological, orodental and pharmacological strategies.Orodental therapies, including soft vinyl mouth guards or stabilization bite splints, probably function more like protectors of the orofacial structures rather than actually diminishing bruxism.Drug treatment of sleep bruxism is controversial since different treatment strategies have resulted in suppression or exacerbation of this condition.

Based on the current data, central primary efferents are the major drivers of bruxism. Therefore centrally acting agents such as antiepileptic drugs which also affect the sleep structure, might be effective on SB.

In a case report of bruxism, anxiety and tremor, the authors suggested that anti-convulsant Gabapentine may be a useful treatment for patients with antidepressant-induced bruxism. However in the absence of definitive evidence, the appropiate treatment of SB is still a matter of debate.

The objective of the present study was to compare the treatment efficacy of occlusal stabilization splint and Gabapentine on SB, using polysomnographically determined outcome measures for the quantification of sleep bruxism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Clinical and polysomnographic criteria of sleep bruxism according to the international classification of sleep disorders

Exclusion Criteria:

• Loss of more than two teeth and having removable prosthesis

• Presence of a major malocclusion

• Using any medication with a known influence on sleep structure or sleep bruxism

• Being diagnosed with psychological or neurotic disorders.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bruxism
• Sleep Bruxism

Intervention

Device:
• occlusal stabilization splint

Drug:
• Gabapentine
100 mg(1 capsule)three times per day for two months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University Of Medical Sciences	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (12)

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Dubé C, Rompré PH, Manzini C, Guitard F, de Grandmont P, Lavigne GJ. Quantitative polygraphic controlled study on efficacy and safety of oral splint devices in tooth-grinding subjects. J Dent Res. 2004 May;83(5):398-403. — View Citation

Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. — View Citation

Kast RE. Tiagabine may reduce bruxism and associated temporomandibular joint pain. Anesth Prog. 2005 Fall;52(3):102-4. — View Citation

Kato T, Thie NM, Huynh N, Miyawaki S, Lavigne GJ. Topical review: sleep bruxism and the role of peripheral sensory influences. J Orofac Pain. 2003 Summer;17(3):191-213. Review. — View Citation

Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x. Review. — View Citation

Lavigne GJ, Rompré PH, Montplaisir JY. Sleep bruxism: validity of clinical research diagnostic criteria in a controlled polysomnographic study. J Dent Res. 1996 Jan;75(1):546-52. — View Citation

Lavigne GJ, Rompré PH, Poirier G, Huard H, Kato T, Montplaisir JY. Rhythmic masticatory muscle activity during sleep in humans. J Dent Res. 2001 Feb;80(2):443-8. — View Citation

Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. Review. — View Citation

Placidi F, Mattia D, Romigi A, Bassetti MA, Spanedda F, Marciani MG. Gabapentin-induced modulation of interictal epileptiform activity related to different vigilance levels. Clin Neurophysiol. 2000 Sep;111(9):1637-42. — View Citation

Saletu A, Parapatics S, Anderer P, Matejka M, Saletu B. Controlled clinical, polysomnographic and psychometric studies on differences between sleep bruxers and controls and acute effects of clonazepam as compared with placebo. Eur Arch Psychiatry Clin Neurosci. 2010 Mar;260(2):163-74. doi: 10.1007/s00406-009-0034-0. Epub 2009 Jul 15. — View Citation

Stapelmann H, Türp JC. The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache - where do we stand? A qualitative systematic review of the literature. BMC Oral Health. 2008 Jul 29;8:22. doi: 10.1186/1472-6831-8-22. — View Citation

* Note: There are 12 references in all — Click here to view all references