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Completed

NCT Number: NCT06593821

Effect of Different Treatment Techniques on Masseter Muscle Thickness

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zonguldak Bülent Ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

Other names: mouthguard

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.

Other names: preventive behaviour

Botulinum toxin

Drug

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

Other names: botox

Primary outcomes

  1. Muscle thickness

    Time frame: 6 months

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

  2. Maximum mouth opening

    Time frame: 6 months

    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.

  3. VAS

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

Evaluation of the Effect of Occlusal Splint and Botulinum Toxin Therapies on Masseter Muscle Thickness and Pain Levels on Bruxism Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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