Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism
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|ClinicalTrials.gov Identifier: NCT01255878|
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : December 8, 2010
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Experimental: stabilization splint||
Device: occlusal stabilization splint
100 mg(1 capsule)three times per day for two months
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 ClinicalTrials.gov identifier (NCT number): NCT01255878
|Iran, Islamic Republic of|
|Mashhad University Of Medical Sciences|
|Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735|
|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|