CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Gabapentine +1 moredrug
Likely dose
Gabapentine 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01255878
NCT01255878N/ACompleted

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

Mashhad University of Medical Sciences·interventional·Posted Dec 8, 2010·Updated Dec 8, 2010

In Brief

A clinical study evaluating occlusal stabilization splint and Gabapentine for Sleep Bruxism. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Bruxism
CountriesIran
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2010
Enrollment StartMar 1, 2010
Primary CompletionSep 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.6 years ago

Interventions

occlusal stabilization splintdevice

Gabapentinedrug

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