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

Primary Purpose

Sleep Bruxism

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
occlusal stabilization splint
Gabapentine
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Bruxism focused on measuring Sleep bruxism, Gabapentine, Occlusal splint, Polysomnography

Eligibility Criteria

18 Years - 50 Years (Adult)All Sexes

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.

Sites / Locations

  • Mashhad University Of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

stabilization splint

Gabapentine

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 7, 2010
Last Updated
December 7, 2010
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01255878
Brief Title
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

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism
Keywords
Sleep bruxism, Gabapentine, Occlusal splint, Polysomnography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stabilization splint
Arm Type
Experimental
Arm Title
Gabapentine
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
occlusal stabilization splint
Intervention Type
Drug
Intervention Name(s)
Gabapentine
Intervention Description
100 mg(1 capsule)three times per day for two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azamsadat Madani, Dr
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nadia Hasanzadeh, Dr
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hasan Azangoo, Dr
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ebrahim Abdollahian, Dr
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Mashhad University Of Medical Sciences
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
10570590
Citation
Brown ES, Hong SC. Antidepressant-induced bruxism successfully treated with gabapentin. J Am Dent Assoc. 1999 Oct;130(10):1467-9. doi: 10.14219/jada.archive.1999.0057.
Results Reference
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PubMed Identifier
15111632
Citation
Dube C, Rompre PH, Manzini C, Guitard F, de Grandmont P, Lavigne GJ. Quantitative polygraphic controlled study on efficacy and safety of oral splint devices in tooth-grinding subjects. J Dent Res. 2004 May;83(5):398-403. doi: 10.1177/154405910408300509.
Results Reference
background
PubMed Identifier
12460250
Citation
Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. doi: 10.1046/j.1528-1157.2002.21002.x.
Results Reference
background
PubMed Identifier
16252740
Citation
Kast RE. Tiagabine may reduce bruxism and associated temporomandibular joint pain. Anesth Prog. 2005 Fall;52(3):102-4. doi: 10.2344/0003-3006(2005)52[102:TMRBAA]2.0.CO;2.
Results Reference
background
PubMed Identifier
14520766
Citation
Kato T, Thie NM, Huynh N, Miyawaki S, Lavigne GJ. Topical review: sleep bruxism and the role of peripheral sensory influences. J Orofac Pain. 2003 Summer;17(3):191-213.
Results Reference
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PubMed Identifier
18557915
Citation
Lavigne GJ, Khoury S, Abe S, Yamaguchi T, Raphael K. Bruxism physiology and pathology: an overview for clinicians. J Oral Rehabil. 2008 Jul;35(7):476-94. doi: 10.1111/j.1365-2842.2008.01881.x.
Results Reference
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PubMed Identifier
11874505
Citation
Lobbezoo F, Naeije M. Bruxism is mainly regulated centrally, not peripherally. J Oral Rehabil. 2001 Dec;28(12):1085-91. doi: 10.1046/j.1365-2842.2001.00839.x.
Results Reference
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PubMed Identifier
10964076
Citation
Placidi F, Mattia D, Romigi A, Bassetti MA, Spanedda F, Marciani MG. Gabapentin-induced modulation of interictal epileptiform activity related to different vigilance levels. Clin Neurophysiol. 2000 Sep;111(9):1637-42. doi: 10.1016/s1388-2457(00)00365-5.
Results Reference
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PubMed Identifier
19603241
Citation
Saletu A, Parapatics S, Anderer P, Matejka M, Saletu B. Controlled clinical, polysomnographic and psychometric studies on differences between sleep bruxers and controls and acute effects of clonazepam as compared with placebo. Eur Arch Psychiatry Clin Neurosci. 2010 Mar;260(2):163-74. doi: 10.1007/s00406-009-0034-0. Epub 2009 Jul 15.
Results Reference
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PubMed Identifier
18662411
Citation
Stapelmann H, Turp JC. The NTI-tss device for the therapy of bruxism, temporomandibular disorders, and headache - where do we stand? A qualitative systematic review of the literature. BMC Oral Health. 2008 Jul 29;8:22. doi: 10.1186/1472-6831-8-22.
Results Reference
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PubMed Identifier
8655758
Citation
Lavigne GJ, Rompre PH, Montplaisir JY. Sleep bruxism: validity of clinical research diagnostic criteria in a controlled polysomnographic study. J Dent Res. 1996 Jan;75(1):546-52. doi: 10.1177/00220345960750010601.
Results Reference
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PubMed Identifier
11332529
Citation
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Results Reference
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Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism

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