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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (C) | Experimental | The control group received only preventive recommendations |
|
| Occlusal splint (O) | Experimental | Occlusal splint applied to the upper jaw |
|
| Botulinum toxin (B) | Experimental | Botulinum toxin injection applied |
|
| Occlusal splint and Botulinum toxin (OB) | Experimental | Both occlusal splint and botulinum toxin were applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Şükriye E Geduk, Asst. Prof. | Zonguldak Bulent Ecevit University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zonguldak Bülent Ecevit University | Zonguldak | Kozlu | 67600 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31302066 | Background | 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. | |
| 19855255 | 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. |
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| ID | Term |
|---|---|
| D002012 | Bruxism |
| C563600 | Masticatory Muscles, Hypertrophy of |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| D009064 | Mouth Protectors |
| D001905 | Botulinum Toxins |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| 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. |
|
|
| Botulinum toxin | Drug | A total of 50 U of botulinum toxin, 25 U in each muscle, was injected |
|
|
| 37180633 | 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. |
| 40935351 | Derived | Tasdemir E, Dogan SE, Gulsen EA, Seker C. Can Occlusal Splint or Botulinum Toxin A Therapy Reduce Masseter Muscle Thickness in Patients With Bruxism? J Oral Maxillofac Surg. 2025 Dec;83(12):1453-1460. doi: 10.1016/j.joms.2025.08.009. Epub 2025 Aug 22. |
| D011313 |
| Preventive Dentistry |
| D003813 | Dentistry |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |