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

NCT01255878 | Completed

• 1 other identifier: 87284
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Bruxism

Keywords

Sleep bruxism; Gabapentine; Occlusal splint; Polysomnography

Study Arms (2)

stabilization splint

EXPERIMENTAL

Device: occlusal stabilization splint

Gabapentine

EXPERIMENTAL

Drug: Gabapentine

Interventions

occlusal stabilization splint DEVICE

stabilization splint

Gabapentine DRUG

100 mg(1 capsule)three times per day for two months

Gabapentine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad University Of Medical Sciences

Mashhad, Khorasan Razavi, 91735, Iran

Location

Related Publications (12)

• Brown ES, Hong SC. Antidepressant-induced bruxism successfully treated with gabapentin. J Am Dent Assoc. 1999 Oct;130(10):1467-9. doi: 10.14219/jada.archive.1999.0057.

  PMID: 10570590 BACKGROUND

• Dube C, Rompre 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. doi: 10.1177/154405910408300509.

  PMID: 15111632 BACKGROUND

• 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. doi: 10.1046/j.1528-1157.2002.21002.x.

  PMID: 12460250 BACKGROUND

• Kast RE. Tiagabine may reduce bruxism and associated temporomandibular joint pain. Anesth Prog. 2005 Fall;52(3):102-4. doi: 10.2344/0003-3006(2005)52[102:TMRBAA]2.0.CO;2.

  PMID: 16252740 BACKGROUND

• 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.

  PMID: 14520766 BACKGROUND

• 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.

  PMID: 18557915 BACKGROUND

• Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. doi: 10.1046/j.1365-2842.2001.00839.x.

  PMID: 11874505 BACKGROUND

• 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. doi: 10.1016/s1388-2457(00)00365-5.

  PMID: 10964076 BACKGROUND

• 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.

  PMID: 19603241 BACKGROUND

• Stapelmann H, Turp 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.

  PMID: 18662411 BACKGROUND

• Lavigne GJ, Rompre 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. doi: 10.1177/00220345960750010601.

  PMID: 8655758 BACKGROUND

• Lavigne GJ, Rompre 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. doi: 10.1177/00220345010800020801.

  PMID: 11332529 BACKGROUND

MeSH Terms

Conditions

Sleep Bruxism

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Azamsadat Madani, Dr

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

• Nadia Hasanzadeh, Dr

  Mashhad University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Hasan Azangoo, Dr

  Mashhad University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Ebrahim Abdollahian, Dr

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 8, 2010

Record last verified: 2010-12

Locations

IR (1)