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Completed

NCT Number: NCT01255878

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mashhad University Of Medical Sciences

Mashhad, Razavi Khorasan Province, 91735, Iran

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

occlusal stabilization splint

Device

Gabapentine

Drug

100 mg(1 capsule)three times per day for two months

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 8, 2010
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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