Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

NCT04871581 | Completed FDA Device

• 1 other identifier: NTI v Placebo
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

Conditions

Chronic Migraine, Headache

Keywords

single blinded study

Outcome Measures

Primary Outcomes (1)

• Improvement of negative impact on life

  At least a one-category improvement in subject's HIT-6 score

  one month

Study Arms (2)

Device

ACTIVE COMPARATOR

Subjects receiving the FDA-cleared device

Device: NTI-tss

Placebo

PLACEBO COMPARATOR

Subjects receiving the sham device

Device: Placebo

Interventions

NTI-tss DEVICE

FDA cleared device for prophylactic treatment of medically diagnosed migraine pain

Device

Placebo DEVICE

Similar to Device, but having no influence on clenching intensity

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• ChairsideSplint.com: lead

Study Sites (1)

Boyd James

Solana Beach, California, 92075, United States

Location

Related Publications (15)

• Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. doi: 10.1097/00019052-200006000-00008.

  PMID: 10871251 BACKGROUND

• 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.

  PMID: 11676887 BACKGROUND

• 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.

  PMID: 16643577 BACKGROUND

• Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x.

  PMID: 15833086 BACKGROUND

• 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.

  PMID: 12207852 BACKGROUND

• 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.

  PMID: 1800695 BACKGROUND

• 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.

  PMID: 3563468 BACKGROUND

• 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.

  PMID: 9656905 BACKGROUND

• Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45.

  PMID: 2259320 BACKGROUND

• 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.

  PMID: 27656052 BACKGROUND

• 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.

  PMID: 11135025 BACKGROUND

• 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.

  PMID: 15189309 BACKGROUND

• 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.

  PMID: 11380790 BACKGROUND

• 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.

  PMID: 15613213 RESULT

• 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.

  PMID: 35246048 DERIVED

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were advised that two different designs of device were being compared to each other.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single blinded cross-over study

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: October 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)