NCT02810015

Brief Summary

Temporomandibular disorders (TMD) are a group of conditions involving the temporomandibular joint (TMJ), masticatory muscles and associated structures. This broad complex of functional disorders often affects the face and jaws causing chronic pain, earaches, headaches, migraines, neck pain, and dysfunction in many people. Patients that do not find benefit with conservative management require surgical intervention. Recently, the use of botulinum toxin has proven effective and has the potential to bridge the gap between conservative therapy and surgical management resulting in less patients requiring invasive surgery. Objective: We aim to treat TMD of muscular origin using Botulinum toxin injections in the trigger points. Methods: Patients, whose pain originates from trigger points, will be enrolled in this prospective trial. This study will evaluate subjective and objective responses to treatment with botulinum toxin. The pair of masticatory muscles, masseter and temporalis, will be injected with 30 units and 20 units of botulinum toxin, respectively. Subjective outcomes such as pain and orofacial function on a visual analog scale as well as objective outcomes such as maximal interincisal mouth opening, tenderness to palpation to the temporalis and masseter muscles, maximal bite force measured by electromyogram and the reduction in muscle bulk due to muscle disuse atrophy will be assessed. Expected Results: We expect trigger points in these patients to disappear and the associated muscles to become partially paralyzed and relaxed. Consequently, we expect that the TMJ loading will be reduced and that the patient's overall functional ability will increase. We also expect that muscular hypertrophy volume from hyperactivity will decrease due to disuse atrophy and impact their cosmetic image positively. Overall, we hope these changes will result in a reduction in pain and headaches which will consequently improve the participant's diet, nutrition, psychological well being and quality of life.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2016

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

June 20, 2016

Last Update Submit

June 20, 2016

Conditions

Temporo-Myofascial Disorder

Outcome Measures

Primary Outcomes (3)

  • Pain (Visual Analog Scale)

    Subjective pain scores will be assessed on a visual analog scale (VAS) where 0 is no pain and 10 is the worst facial or jaw pain they've ever experience. Subjective functional assessments will also be assessed with VAS where 0 means no limitation and 10 indicates severe limitation with scales for chewing, drinking, exercising, eating hard food, eating soft food, smiling or laughing, cleaning their teeth, yawning, swallowing and talking.

    3 months

  • Range of Motion

    Range of motion will be assessed with a Boley gauge between the same upper and lower incisor each time

    3 months

  • Palpation tenderness

    Pain to pressure will be ranked from 0 to 5, with 0 indicating no pain and 5 representing extreme debilitating pain. Addition of each score will give a composite score of the overall facial tenderness out of a maximal score of 24 (2 areas X 6 scores X bilaterally).

    3 months

Secondary Outcomes (1)

  • Facial Width

    3 months

Study Arms (1)

Botulinum Toxin A

EXPERIMENTAL

BTX-A will be reconstituted as directed by the manufacturer. 2.5 mL of diluent (0.9% Saline) per 100 U vial will be used to reconstitute the solution while swirling. This creates a solution with a concentration of 4 U/0.1 mL. Patients will be seated and all usual precautions of sterility and skin preparation will be completed (i.e. alcohol wipes) Injections will be administered unilateral and/or bilaterally in accordance with the topography of the corresponding muscles (temporalis and masseter) into areas of maximal tenderness and pain. Plastic single use insulin syringes with 30 gauge needles will be used to inject 30 U intramuscularly into each masseter, divided evenly into 5 sites and 20 U will be injected into each temporalis, divided evenly over 5 sites. Injections will be completed by the principal investigator and supervisors who will be trained in botulinum toxin injections.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type ADRUG

BTX-A will be reconstituted as directed by the manufacturer. 2.5 mL of diluent (0.9% Saline) per 100 U vial will be used to reconstitute the solution while swirling. This creates a solution with a concentration of 4 U/0.1 mL. Patients will be seated and all usual precautions of sterility and skin preparation will be completed (i.e. alcohol wipes) Injections will be administered unilateral and/or bilaterally in accordance with the topography of the corresponding muscles (temporalis and masseter) into areas of maximal tenderness and pain. Plastic single use insulin syringes with 30 gauge needles will be used to inject 30 U intramuscularly into each masseter, divided evenly into 5 sites and 20 U will be injected into each temporalis, divided evenly over 5 sites. Injections will be completed by the principal investigator and supervisors who will be trained in botulinum toxin injections.

Botulinum Toxin A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant's with trigger points in their masticatory muscles including, but not limited to: masseter and temporalis either bilateral or unilateral and secondly
  • have tried conservative management for at least 3 months and have shown to be refractory to these interventions.

You may not qualify if:

  • currently are breastfeeding or pregnant
  • participant's whose TMD is not muscular in origin
  • inability to speak or understand English
  • the inability to provide meaningful informed consent due to physical, cognitive or psychiatric disability
  • a previous known allergy to Botulinum toxin
  • multiple sclerosis
  • pre-existing neuromuscular disorders
  • Lambert-Eaton syndrome
  • chronic centrally mediated neuralgic pain patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (60)

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MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Reda Elgazzar, DMD

    University of Manitoba

    STUDY DIRECTOR

Central Study Contacts

Victor Le, DMD

CONTACT

2049143018victor.le101@gmail.com

Adnan Shah, DMD

CONTACT

204-963-1962adnan.shah@umanitoba.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

June 1, 2019

Last Updated

June 22, 2016

Record last verified: 2016-06