Clinical trial NCT01255878: Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism
Official title: The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Bruxism
Keywords: Sleep bruxism
Gabapentine
Occlusal splint
Polysomnography
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University Of Medical Sciences
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Azamsadat Madani, Dr
role: STUDY_DIRECTOR
affiliation: Mashhad University of Medical Sciences
name: Nadia Hasanzadeh, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mashhad University of Medical Sciences
name: Hasan Azangoo, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mashhad University of Medical Sciences
name: Ebrahim Abdollahian, Dr
role: STUDY_DIRECTOR
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