Occlusal Splints or Botulinum Toxin?

NCT03891121 | Completed

• 1 other identifier: 36290600/49
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain; Temporomandibular Disorder

Keywords

Myofascial Pain; Botulinum Toxin

Outcome Measures

Primary Outcomes (5)

• VAS

  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.

  1 minute

• TMD-PS

  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.

  2 minutes

• GCPS

  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.

  2 minutes

• JFLS

  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.

  3 minutes

• OBC

  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.

  5 minutes

Study Arms (3)

Occlusal splint

EXPERIMENTAL

Patients were treated with occlusal splint.

Device: Occlusal Splint

Botulinum toxin

EXPERIMENTAL

Patients were treated with botulinum toxin injection.

Drug: Botulinum toxin type A

Both

EXPERIMENTAL

Patients were treated with occlusal splint and botulinum toxin injection together.

Device: Occlusal Splint; Drug: Botulinum toxin type A

Interventions

Occlusal Splint DEVICE

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.

Both; Occlusal splint

Botulinum toxin type A DRUG

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.

Both; Botulinum toxin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (5)

• Ohrbach R, Larsson P, List T. The jaw functional limitation scale: development, reliability, and validity of 8-item and 20-item versions. J Orofac Pain. 2008 Summer;22(3):219-30.

  PMID: 18780535 BACKGROUND

• Freund B, Schwartz M, Symington JM. Botulinum toxin: new treatment for temporomandibular disorders. Br J Oral Maxillofac Surg. 2000 Oct;38(5):466-71. doi: 10.1054/bjom.1999.0238.

  PMID: 11010775 BACKGROUND

• Lee SJ, McCall WD Jr, Kim YK, Chung SC, Chung JW. Effect of botulinum toxin injection on nocturnal bruxism: a randomized controlled trial. Am J Phys Med Rehabil. 2010 Jan;89(1):16-23. doi: 10.1097/PHM.0b013e3181bc0c78.

  PMID: 19855255 BACKGROUND

• Guarda-Nardini L, Manfredini D, Salamone M, Salmaso L, Tonello S, Ferronato G. Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study. Cranio. 2008 Apr;26(2):126-35. doi: 10.1179/crn.2008.017.

  PMID: 18468272 RESULT

• Kurtoglu C, Gur OH, Kurkcu M, Sertdemir Y, Guler-Uysal F, Uysal H. Effect of botulinum toxin-A in myofascial pain patients with or without functional disc displacement. J Oral Maxillofac Surg. 2008 Aug;66(8):1644-51. doi: 10.1016/j.joms.2008.03.008.

  PMID: 18634953 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Oral and Maxillofacial Surgery Specialist

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 26, 2019
• Study Start: April 5, 2018
• Primary Completion: February 15, 2019
• Study Completion: March 10, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)