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Eighty individuals (44 female, 36 male), which were randomly divided into 4 groups of 20 patients each, due to the treatment type: Botulinum toxin (BTX); Dry needling (DN); Pharmacological therapy (PT) and Manual therapy (MT). All treatments were carried out by the same maxillofacial surgeon. An informed consent form was obtained from all participants.
The study aimed to assess and compare the effectiveness of 4 different methods in the management bruxism: Botulinum toxin (BTX-A), dry needling (DN), pharmacological therapy (PT), and manual therapy (MT). 80 bruxist patients (44 female, 36 male) were randomly divided into 4 groups of 20 patients each. Botulinum toxin, dry needling, pharmacological therapy and manual therapy were carried out by the same maxillofacial surgeon in all patients. The following measurements were recorded by another investigator in each group, at baseline (before treatment) and at post-treatment intervals of 2nd, 4th, and 12th weeks; Visual Analogue Scale (VAS) for pain, maximum painless mouth opening (mm), Oral Health Impact Profile14 (OHIP-14).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | A single session of Botox (Botulinum toxin A) injection was performed. 50 IU was administered bilaterally by intramuscular injection: 30 IU within the masseter muscles and 20 IU within the anterior temporalis muscles. |
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| Group 2 | Active Comparator | Dry needling was performed using sterile plastic cylindrical guide needles (25 mm length, 0.25 mm diameter) The needles were inserted 5 mm deep into hypertonic and irritable nodules (trigger points, TrPs) within the masseter and temporalis muscles. Each needle was rotated twice clockwise and then removed after remaining in the TrPs for a total of 20 minutes. The treatment was administered in three sessions, each one week apart. |
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| Group 3 | Active Comparator | Pharmacological treatment was administered by prescribing Miyorel, a combination of methocarbamol (380 mg) and paracetamol (300 mg). The prescribed dosage was two tablets, taken three times daily, for a period of three weeks. |
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| Group 4 | Active Comparator | Manual therapy was administered, consisting of bilateral facial massage and stretching maneuvers targeting the masseter and temporalis muscles. This treatment was performed for 20 minutes daily over a period of three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug | Botulinum toxin, produced by Clostridium botulinum, is a neurotoxin. Presently, there are 7 serotypes (A, B, C1, D, E, F, G). Botulinum neurotoxin A (BoNT-A) is the most frequently used variant in clinical applications. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain in at rest and at chewing | Average pain was measured by a scale, named Visual analogue scale. | 12 weeks |
| MMO | Maximum painless mouth opening (in millimeters) was measured by a special ruler. | 12 weeks |
| OHRQoL questionnaire | Oral-health-related quality of life | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALANUR CIFTCI SISMAN, PhD | Saglik Bilimleri Universitesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39800961 | Derived | Sahin SS, Ciftci Sisman A, Atar E, Kilac H, Guzelce Sultanoglu E. Comparison of the effectiveness of botulinum toxin, dry needling, pharmacological treatment, and manual therapy for bruxism-induced myalgia: a prospective randomized study. J Oral Facial Pain Headache. 2024 Dec;38(4):101-110. doi: 10.22514/jofph.2024.043. Epub 2024 Dec 12. |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D002012 | Bruxism |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| C545476 | incobotulinumtoxinA |
| D000079245 | Dry Needling |
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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Group 1: Botulinum toxin (BTX-A) injection (n=20) Group 2: Dry needling (DN) (n=20) Group 3: Pharmacological therapy (PT) (n=20) Group 4: Manual therapy (MT) (n=20)
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Participants were informed only about the type of treatment they received. The results were measured and recorded by another researcher other than the operator.
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| Dry needling | Procedure | Dry needling (DN) is a type of acupuncture therapy, that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points (MTrPs) and muscular, and connective tissues. |
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| Myorel | Drug | Metacarbamol (380mg), paracetamol (300mg) |
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| Manual therapy | Procedure | Manual therapy (MT) entails the use of the hands to apply a force with a therapeutic intent, including techniques such as massage, joint mobilization/manipulation, myofascial release, nerve manipulation, strain/counterstrain, and acupressure. |
|
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D006184 | Habits |
| D001519 | Behavior |
| 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 |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |