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CompletedNCT06593821Updated Sep 19, 2024

Effect of Different Treatment Techniques on Masseter Muscle Thickness

An interventional study of Occlusal splint and preventive advice in Bruxism and Masseter Muscle Hypertrophy, sponsored by Zonguldak Bulent Ecevit University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Zonguldak Bulent Ecevit University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2023, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The study was carried out on 48 patients between 21 and 52 years, who attended the clinic with the complaints of bruxism. The first group was referred to as the Control group (C) and 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. The second group was treated with an occlusal splint (O), the third group with an injection of botulinum toxin (B), and the fourth group with both an occlusal splint and an injection of botulinum toxin (OB). At the beginning of the treatment and after 1, 3 and 6 months, the thickness of the masseter muscles of all patients was measured bilaterally by ultrasound in relaxed and contracted positions. Maximum mouth opening values was recorded by measuring the distance between the incisal edges of the maxillary and mandibular first incisors (teeth 11 and 41) using calipers. Pain levels were assessed using the Visual Analogue Scale (VAS), where patients marked their pain severity on a 10 cm unmarked straight line, with scores ranging from 0 to 10.

Ultrasound measurements Masseter muscle thickness measurements were performed by the same radiologist, using a MyLabTMTwice ultrasound device equipped with a linear probe with a frequency range of 4-13 megahertz. To ensure reproducibility, the probe was positioned perpendicular to the ramus, aligned with the imaginary line between the corner of the lip and the inferior border of the tragus. Measurements were taken at the thickest part of the masseter muscle, with bilateral assessments in both the relaxed and contracted states.

Application of the occlusal splint The occlusal splint was fabricated from a 2 mm hard splinting resin material on the plaster model obtained by taking impressions of the patient's upper jaw. Centric and eccentric occlusal relationships were assessed to ensure equal contact between all teeth. Patients were instructed to wear the splint overnight for at least 8 hours. Patients were also educated on the care and maintenance of the splint and compliance was checked at follow-up visits.

Botulinum toxin injection All injections were administered by the same specialist maxillofacial surgeon. For each dose of 1.0 U/0.1 mL, 100 U of lyophilized botulinum toxin was diluted with 2 cc of saline. The skin area was cleansed with povidone iodine and dried. The anterior, posterior, superior and inferior borders of the masseter muscle were marked to ensure safe injection. Before injection, patients were instructed to clench their teeth to make the injection sites more visible. Intramuscular injections were performed with the needle perpendicular to the skin. A total of 50 U of botulinum toxin was injected , 25 U in each muscle, using 30-gauge injectors.

02

Conditions studied

  • Bruxism
  • Masseter Muscle Hypertrophy

Keywords

  • Botulinum toxin
  • Bruxism
  • Masseter muscle hypertrophy
  • Occlusal splint
  • Ultrasound
03

In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's enrollment of 48 is above the median of 38 across 103 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Zonguldak Bulent Ecevit University is the lead sponsor of 96 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Control (C)

    The control group received only preventive recommendations

    Behavioral: preventive advice

  • Experimental
    Occlusal splint (O)

    Occlusal splint applied to the upper jaw

    Device: Occlusal splint

  • Experimental
    Botulinum toxin (B)

    Botulinum toxin injection applied

    Drug: Botulinum toxin

  • Experimental
    Occlusal splint and Botulinum toxin (OB)

    Both occlusal splint and botulinum toxin were applied

    Device: Occlusal splint · Drug: Botulinum toxin

Interventions

  • DeviceOcclusal splint

    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

  • Behavioralpreventive advice

    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

  • DrugBotulinum toxin

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

    Also known as: botox

06

What researchers measure

Primary outcomes

  1. Muscle thickness

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

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

  3. VAS

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

    Time frame: 6 months

07

Study locations

1 site
  • Zonguldak Bülent Ecevit University
    Zonguldak, Kozlu 67600, Turkey
08

References and documents

Publications

  • 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. PubMed 31302066 ↗
  • 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. PubMed 19855255 ↗
  • 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. PubMed 37180633 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06593821
Lead sponsor
Zonguldak Bulent Ecevit University
Responsible party
Şükriye Ece Geduk (Assistant Professor, Zonguldak Bulent Ecevit University) — Principal investigator
First posted
Sep 19, 2024
Start date
Apr 3, 2023
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024
Last update
Sep 19, 2024

Study contacts

Şükriye E Geduk, Asst. Prof.
study director · Zonguldak Bulent Ecevit University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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