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Occlusal Splints or Botulinum Toxin?

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ClinicalTrials.gov Identifier: NCT03891121
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mehmet Emre Yurttutan, Ankara University

Brief Summary:
73 patients with myofascial pain due to bruxism were included in this study. The patient were allocated into three groups. Group A was treated with occlusal splint, Group B was treated with botulinum toxin injection, Group C was treated with occlusal splint and botulinum toxin injection together. Temporomandibular Disorder Pain Screener (TMD-PS), Graded Chronic Pain Scale (GCPS), Oral Behavior Checklist (OBC), Jaw Function Limitation Scale (JFLS), Visual Analog Scale (VAS) by palpation of the chewing muscles were administered to all patients before treatment and at 6 months after treatment.

Condition or disease Intervention/treatment Phase
Myofascial Pain Temporomandibular Disorder Device: Occlusal Splint Drug: Botulinum toxin type A Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Which One is Effective in Treatment of Bruxism? Occlusal Splints or Botulinum Toxin
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : March 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Occlusal splint
Patients were treated with occlusal splint.
Device: Occlusal Splint
Occlusal splints are appliances that were usually applied to the upper jaw and covering all teeth and they are made of autopolymerizing acrylic resin. It is produced by using 2 mm thick hard acrylic between the maxilla and mandible as defined by the Okeson.

Experimental: Botulinum toxin
Patients were treated with botulinum toxin injection.
Drug: Botulinum toxin type A
We diluted 100-U freeze-dried BTX-A with 1.0 milliliters of sodium chloride, resulting in a dose of 1.0 U per 0.1 mL. We administered all skin injections by using a 1-inch 30-gauge needle. Patients were placed with the Frankfurt horizontal plane parallel to the floor.

Experimental: Both
Patients were treated with occlusal splint and botulinum toxin injection together.
Device: Occlusal Splint
Occlusal splints are appliances that were usually applied to the upper jaw and covering all teeth and they are made of autopolymerizing acrylic resin. It is produced by using 2 mm thick hard acrylic between the maxilla and mandible as defined by the Okeson.

Drug: Botulinum toxin type A
We diluted 100-U freeze-dried BTX-A with 1.0 milliliters of sodium chloride, resulting in a dose of 1.0 U per 0.1 mL. We administered all skin injections by using a 1-inch 30-gauge needle. Patients were placed with the Frankfurt horizontal plane parallel to the floor.




Primary Outcome Measures :
  1. VAS [ Time Frame: 1 minute ]
    Visual Analog Scale:Patients' pain was examined by palpation of the chewing muscles and the pain was marked from 0 to 10 on the VAS before and after the treatment. Higher values represent a worse outcome.

  2. TMD-PS [ Time Frame: 2 minutes ]
    TMD Pain Screener is a self-report, simple, reliable questionnaire used to assess for the presence of any pain-related TMD. Full version with 6 questions were applied. The total score is between 0 and 7. If the total score is between 0 and 3 points, there is no TMD. If the total score is between 4 and 7, there is TMD. Higher values represent a worse outcome.

  3. GCPS [ Time Frame: 2 minutes ]
    Graded Chronic Pain Scale is a reliable, short and valid tool that evaluates pain intensity and pain related disability with 7 questions. After the scoring, it is classified to 5 grades. Grade 0 with no intensity and disability, Grade 1 with low intensity and low disability, Grade 2 high intensity and low disability, Grade 3 with high disability and moderately limiting, Grade 4 with high disability and severely limiting. Higher values represent a worse outcome.

  4. JFLS [ Time Frame: 3 minutes ]
    Jaw Function Limitation Scale evaluates the universal limitations on chewing, jaw mobility, verbal and emotional expression. The patient indicates the level of limitation the mentioned activities from 0 to 10.Higher values represent a worse outcome.

  5. OBC [ Time Frame: 5 minutes ]
    Oral Behaviors Checklist evaluates the effects of oral parafunctional habits on the masticatory system and the frequency of these habits. Scoring can be computed as the sum of the number of 21 items and the total score is between 21 and 105. Higher values represent a worse outcome.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years with chronic myofascial pain
  • More than 6 months with myofascial pain
  • Diagnosis of myofascial pain according to the RDC/TMD

Exclusion Criteria:

  • Patients having intracapsular TMD (disc displacement with or without reduction)
  • A history of any treatment for bruxism, patients taking aminoglycosides
  • Penicillamine
  • Quinine and calcium blockers
  • Pregnant or lactating mothers
  • Having neuromuscular disorder (e.g. Orofacial tardive dyskinesia, Lambert-Eaton Syndrome, Myasthenia gravis)
  • Having rheumatoid arthritis
  • Having temporomandibular joint osteoarthrosis with radiographic signs
  • History of previous joint surgery
  • Patients who had undergone BTX treatment before or an allergy to BTX-A

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 ClinicalTrials.gov identifier (NCT number): NCT03891121


Locations
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Turkey
Ankara University, Faculty of Dentistry
Ankara, Turkey, 06500
Sponsors and Collaborators
Ankara University

Publications of Results:
Other Publications:
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Responsible Party: Mehmet Emre Yurttutan, DDS, PhD, Oral and Maxillofacial Surgery Specialist, Ankara University
ClinicalTrials.gov Identifier: NCT03891121     History of Changes
Other Study ID Numbers: 36290600/49
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Mehmet Emre Yurttutan, Ankara University:
Myofascial Pain
Botulinum Toxin
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
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