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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255878
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : December 8, 2010
Information provided by:
Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Sleep Bruxism Device: occlusal stabilization splint Drug: Gabapentine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial
Study Start Date : March 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: stabilization splint Device: occlusal stabilization splint
Experimental: Gabapentine Drug: Gabapentine
100 mg(1 capsule)three times per day for two months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255878

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Iran, Islamic Republic of
Mashhad University Of Medical Sciences
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
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Study Director: Azamsadat Madani, Dr Mashhad University of Medical Sciences
Principal Investigator: Nadia Hasanzadeh, Dr Mashhad University of Medical Sciences
Principal Investigator: Hasan Azangoo, Dr Mashhad University of Medical Sciences
Study Director: Ebrahim Abdollahian, Dr Mashhad University of Medical Sciences


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Responsible Party: Mashhad University of Medical Sciences Identifier: NCT01255878     History of Changes
Other Study ID Numbers: 87284
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010
Keywords provided by Mashhad University of Medical Sciences:
Sleep bruxism
Occlusal splint
Additional relevant MeSH terms:
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Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents