Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism
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Purpose
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 | Intervention |
|---|---|
|
Sleep Bruxism |
Device: occlusal stabilization splint Drug: Gabapentine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial |
| Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: stabilization splint | Device: occlusal stabilization splint |
| Experimental: Gabapentine |
Drug: Gabapentine
100 mg(1 capsule)three times per day for two months
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations| 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 |
More Information
Publications:
| Responsible Party: | Mashhad University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01255878 History of Changes |
| Other Study ID Numbers: | 87284 |
| Study First Received: | December 7, 2010 |
| Last Updated: | December 7, 2010 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Mashhad University of Medical Sciences:
|
Sleep bruxism Gabapentine Occlusal splint Polysomnography |
Additional relevant MeSH terms:
|
Bruxism Sleep Bruxism Tooth Diseases Stomatognathic Diseases Parasomnias Sleep Disorders Nervous System Diseases Mental Disorders |
Salicylic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on June 13, 2013