Botox vs Occlusal Splint for Masseter Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03456154
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : November 15, 2018
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Brief Summary:
This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.

Condition or disease Intervention/treatment Phase
Pain, Face Drug: Botox Injectable Product Device: Occlusal splint Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : August 15, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botox
In this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day.
Drug: Botox Injectable Product
60u will be used at 3 sites of masseter muscle, on each side of the face

Active Comparator: Occlusal splint
In this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night.
Device: Occlusal splint
In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

Primary Outcome Measures :
  1. Pain [ Time Frame: baseline, 3 and 6 months ]
    VAS will be used to assess decrease of pain

Secondary Outcome Measures :
  1. Oral health related quality of life [ Time Frame: baseline, 3 and 6 months ]
    OHIP 14 questionnaire will be applied

  2. Cervical Position [ Time Frame: baseline, 3 and 6 months ]
    Modifications of cervical vertebral column position will be assessed

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Between 18 and 70 years old;
  • at least 20 teeth in the mouth;
  • occlusal stability;
  • presenting pain in face muscles.

Exclusion Criteria:

  • Angle's Class III
  • Kennedy's Class II or I removable partial denture wearer;
  • Complete denture wearer;
  • Individuals that have taken any anti inflammatory drugs in the last 3 months;
  • Individuals with temporomandibular joint disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03456154

Federal University of Pelotas Recruiting
Pelotas, Rio Grande Do Sul, Brazil, 96015560
Contact: Maximiliano Cenci, PhD    555332256741 ext 135   
Contact: Tatiana Cenci, PhD    5553   
Sponsors and Collaborators
Federal University of Pelotas

Responsible Party: Maximiliano Sergio Cenci, PhD, Federal University of Pelotas Identifier: NCT03456154     History of Changes
Other Study ID Numbers: PPGO022
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Salicylic Acid
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents