- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255878
Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism
The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Khorasan Razavi
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Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
- Mashhad University Of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: stabilization splint
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|
Experimental: Gabapentine
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100 mg(1 capsule)three times per day for two months
|
Collaborators and Investigators
Investigators
- 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
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Wake Disorders
- Stomatognathic Diseases
- Parasomnias
- Tooth Diseases
- Bruxism
- Sleep Bruxism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Anticonvulsants
- Antimanic Agents
- Gabapentin
Other Study ID Numbers
- 87284
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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