Botox for Treatment of TMJ Disorder With Bruxism

NCT02202070 | Withdrawn Phase 1 DMC

• 1 other identifier: AAHEJB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Myofascial temporomandibular joint disorder and related symptoms are associated with mandibular condyle and temporal fossa overloading secondary to temporalis and masseter muscle hyperactivity and spasm This study will examine the use of onabotulinumtoxinA (Botox) to treat myofascial pain disorder in patients with bruxism who frequently exhibit signs of temporomandibular joint disorder (TMD) in a double blind cross-over randomized clinical trial by injecting 50 units Botox in temporalis and masseter muscles in 32 patients with 6 months follow up. The objective of the proposed study will be to establish the safety and efficacy of botox in treating TMD associated with bruxism. By the time patients reach the specialists office, most have failed maximal conservative therapies, including non-chew diet, night guard, oral analgesics, muscle relaxants, physical therapy, and a portion have even undergone more invasive procedures, such as manipulation under anesthesia, arthroscopy, and arthroplasty surgeries with limited improvement or recurrence. Primary outcome of the study will be 50% reduction in pain. Secondary outcomes will be 50% reduction in surgical therapy, 25% increase in maximal inter-incisal opening (MIO). The investigators look forward to working with you on the proposed study

Conditions

Temporomandibular Joint Disorders; Bruxism; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint

Keywords

onabotulinumtoxinA; Temporomandibular Joint Disorders; Bruxism; Temporomandibular Joint Dysfunction Syndrome; Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint

Outcome Measures

Primary Outcomes (1)

• 50% reduction in pain

  Patients will be seen in clinic every 3 months and asked to fill out questionaire. Questionaire will include with visual analogue scale (VAS) average pain over previous week, month

  6 months

Secondary Outcomes (1)

• 25% increase in maximal opening at incisors

  6 months

Other Outcomes (1)

• 50% reduction in progression of disease to surgery

  6 months

Study Arms (2)

Botox injection first, followed by placebo

EXPERIMENTAL

50 units Botox injection in masseter and temporalis muscles in the first 3 months, then second injection of normal saline at placebo in second 3 months

Drug: onabotulinumtoxinA

Placebo injection first, followed Botox

EXPERIMENTAL

Injection of normal saline at placebo in first 3 months, then 50 units Botox injection in masseter and temporalis muscles in the second 3 months.

Drug: onabotulinumtoxinA

Interventions

onabotulinumtoxinA DRUG

Also known as: BOTOX

Botox injection first, followed by placebo; Placebo injection first, followed Botox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 persons with a diagnosis of myofascial temporomandibular joint disorder refractory to conservative treatment for 6 months

You may not qualify if:

• pregnancy
• rheumatoid arthritis
• ankylosing spondylitis
• psoriatic arthritis
• fibromyalgia
• neuropathic pain
• pain of dental origin
• muscle relaxant use
• aminoglycoside use
• prior Botox use
• neuropathic pain
• trigeminal neuralgia

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism; Temporomandibular Joint Dysfunction Syndrome

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Myofascial Pain Syndromes

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Alan A Harvey, DMD

  Assistant Professor, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic surgery resident physician

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 28, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)