Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device
NCT ID: NCT04871581
Last Updated: 2021-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-10-01
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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Device
Subjects receiving the FDA-cleared device
NTI-tss
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
Placebo
Subjects receiving the sham device
Placebo
Similar to Device, but having no influence on clenching intensity
Interventions
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NTI-tss
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
Placebo
Similar to Device, but having no influence on clenching intensity
Eligibility Criteria
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Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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ChairsideSplint.com
INDUSTRY
Responsible Party
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Locations
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Boyd James
Solana Beach, California, United States
Countries
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References
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Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. doi: 10.1097/00019052-200006000-00008.
Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001 Dec;5(6):529-36. doi: 10.1007/s11916-001-0070-6.
Rozen TD. Migraine prevention: what patients want from medication and their physicians (a headache specialty clinic perspective). Headache. 2006 May;46(5):750-3. doi: 10.1111/j.1526-4610.2006.00429.x.
Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.
Graff-Radford SB, Newman AC. The role of temporomandibular disorders and cervical dysfunction in tension-type headache. Curr Pain Headache Rep. 2002 Oct;6(5):387-91. doi: 10.1007/s11916-002-0081-y.
Steele JG, Lamey PJ, Sharkey SW, Smith GM. Occlusal abnormalities, pericranial muscle and joint tenderness and tooth wear in a group of migraine patients. J Oral Rehabil. 1991 Sep;18(5):453-8. doi: 10.1111/j.1365-2842.1991.tb01690.x.
Lamey PJ, Barclay SC. Clinical effectiveness of occlusal splint therapy in patients with classical migraine. Scott Med J. 1987 Feb;32(1):11-2. doi: 10.1177/003693308703200105.
Clark GT, Sakai S, Merrill R, Flack VF, McArthur D, McCreary C. Waking and sleeping temporalis EMG levels in tension-type headache patients. J Orofac Pain. 1997 Fall;11(4):298-306.
Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45.
Yap AU, Chua AP. Sleep bruxism: Current knowledge and contemporary management. J Conserv Dent. 2016 Sep-Oct;19(5):383-9. doi: 10.4103/0972-0707.190007.
Burnett CA, Fartash L, Murray B, Lamey PJ. Masseter and temporalis muscle EMG levels and bite force in migraineurs. Headache. 2000 Nov-Dec;40(10):813-7. doi: 10.1046/j.1526-4610.2000.00147.x.
Chandu A, Suvinen TI, Reade PC, Borromeo GL. The effect of an interocclusal appliance on bite force and masseter electromyography in asymptomatic subjects and patients with temporomandibular pain and dysfunction. J Oral Rehabil. 2004 Jun;31(6):530-7. doi: 10.1111/j.1365-2842.2004.01377.x.
Nishigawa K, Bando E, Nakano M. Quantitative study of bite force during sleep associated bruxism. J Oral Rehabil. 2001 May;28(5):485-91. doi: 10.1046/j.1365-2842.2001.00692.x.
Castillo J, Munoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6. doi: 10.1046/j.1526-4610.1999.3903190.x.
Blumenfeld AM, Boyd JP. Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study. BMC Neurol. 2022 Mar 4;22(1):72. doi: 10.1186/s12883-022-02591-8.
Other Identifiers
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NTI v Placebo
Identifier Type: -
Identifier Source: org_study_id
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