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

Not Applicable

Completed

• Conditions: Sleep Bruxism
• Interventions: Device: occlusal stabilization splint; Drug: Gabapentine

• Registration Number: NCT01255878
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-07
• Last Update Submitted: 2010-12-07
• Study First Posted: 2010-12-08
• Last Update Posted: 2010-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stabilization splint	occlusal stabilization splint	-
Gabapentine	Gabapentine	-

Trial Locations

Locations (1)

Mashhad University Of Medical Sciences; 🇮🇷 Mashhad, Khorasan Razavi, Iran, Islamic Republic of