Effect of Different Treatment Techniques on Masseter Muscle Thickness

NCT06593821 | Completed

• 1 other identifier: 2023/14-4836
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of different treatment techniques on masseter muscle thickness, pain levels and maximum mouth opening in patients with bruxism. The null hypothesis of the study is that there is no difference between the use of an occlusal splint and botulinum toxin on masseter muscle thickness in patients with bruxism.

Conditions

Bruxism; Masseter Muscle Hypertrophy

Keywords

Botulinum toxin; Bruxism; Masseter muscle hypertrophy; Occlusal splint; Ultrasound

Outcome Measures

Primary Outcomes (3)

• Muscle thickness

  Both relaxed and contracted masseter muscle thicknesses were measured by ultrasonography 1, 3 and 6 months after treatment.

  6 months

• Maximum mouth opening

  The maximum mouth opening of the patients 1, 3 and 6 months after treatment was recorded by measuring the incisal distance between the upper and lower central incisors.

  6 months

• VAS

  Patients were asked to rate their pain levels from 1 to 10 at 1, 3 and 6 months after treatment.

  6 months

Study Arms (4)

Control (C)

EXPERIMENTAL

The control group received only preventive recommendations

Behavioral: preventive advice

Occlusal splint (O)

EXPERIMENTAL

Occlusal splint applied to the upper jaw

Device: Occlusal splint

Botulinum toxin (B)

EXPERIMENTAL

Botulinum toxin injection applied

Drug: Botulinum toxin

Occlusal splint and Botulinum toxin (OB)

EXPERIMENTAL

Both occlusal splint and botulinum toxin were applied

Device: Occlusal splint; Drug: Botulinum toxin

Interventions

Occlusal splint DEVICE

The occlusal splint was fabricated from a 2 mm hard splinting resin material on the plaster model obtained by taking impressions of the patients\' upper jaw.

Also known as: mouthguard

Occlusal splint (O); Occlusal splint and Botulinum toxin (OB)

preventive advice BEHAVIORAL

Control group given protective advice such as supporting the jaw when yawning, not chewing gum, not opening the mouth for too long and not opening it too wide, and chewing on both sides when eating.

Also known as: preventive behaviour

Control (C)

Botulinum toxin DRUG

A total of 50 U of botulinum toxin, 25 U in each muscle, was injected

Also known as: botox

Botulinum toxin (B); Occlusal splint and Botulinum toxin (OB)

Eligibility Criteria

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

You may qualify if:

• Who volunteered to participate in the study,
• Eighteen years of age or older,
• Has not received any treatment for bruxism before,
• Systemically healthy,
• Visible tooth wear,
• History of clenching or grinding with masticatory pain,
• Morning temporomandibular joint (TMJ) stiffness,
• Masseter hypertrophy

You may not qualify if:

• Systemic disease,
• Under the age of eighteen,
• Having received any pharmacological, dental, etc. treatment for bruxism before,
• With any known drug allergy,
• During pregnancy or breastfeeding,
• Bleeding irregularities,
• With mental retardation,
• Active orthodontic treatment

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (3)

• Yurttutan ME, Tutunculer Sancak K, Tuzuner AM. Which Treatment Is Effective for Bruxism: Occlusal Splints or Botulinum Toxin? J Oral Maxillofac Surg. 2019 Dec;77(12):2431-2438. doi: 10.1016/j.joms.2019.06.005. Epub 2019 Jun 19.

  PMID: 31302066 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

• Erdil D, Bagis N, Eren H, Camgoz M, Orhan K. The Evaluation of the Relationship between Changes in Masseter Muscle Thickness and Tooth Clenching Habits of Bruxism Patients Treated with Botulinum Toxin A. J Med Ultrasound. 2022 Aug 18;31(1):22-28. doi: 10.4103/jmu.jmu_51_22. eCollection 2023 Jan-Mar.

  PMID: 37180633 BACKGROUND

MeSH Terms

Conditions

Bruxism; Masticatory Muscles, Hypertrophy of

Interventions

Occlusal Splints; Mouth Protectors; Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Preventive Dentistry; Dentistry; Protective Devices; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; 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

• Şükriye E Geduk, Asst. Prof.

  Zonguldak Bulent Ecevit University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: April 3, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)