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This randomized clinical trial will compare the standard treatment (occlusal splint) and botox for the treatment of face muscular pain in adults. Fifty patients will be invited and selected, and allocated to the experimental group, according to the randomization sequence previously performed. For the splint group, a rigid splint will be worn by the patient every night. For the botox group, 60u of botox will be injected in 3 regions of the masseter muscle. Patients will be assessed before the experiment, 3 and 6 months after the beginning of the study. Oral health related quality of life, pain, and cervical neck position will be evaluated. Paired t-test and chi-square will be used for statistical analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botox | Experimental | In this group patients will receive 3 injections of botox on each masseter (left and right), after randomization. This injection will be performed once, and the patient will be evaluated after 3 and 6 months after this day. |
|
| Occlusal splint | Active Comparator | In this group patients will receive an occlusal splint, which will be manufactured after taking their full mouth impression. This appliance has to be worn everyday, for 6 months, at night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox Injectable Product | Drug | 60u will be used at 3 sites of masseter muscle, on each side of the face |
|
| Measure | Description | Time Frame |
|---|---|---|
| Masticatory muscle pain | VAS will be used to assess decrease of pain | baseline, 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oral health related quality of life | OHIP 14 questionnaire will be applied | baseline, 3 and 6 months |
| Cervical Position | Modifications of cervical vertebral column position will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Pelotas | Pelotas | Rio Grande do Sul | 96015560 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39593526 | Derived | Pires ALC, Galdino Santos L, Poletto-Neto V, Luz MS, Damian MF, Pereira-Cenci T. Evaluation of craniocervical posture after myofascial pain treatment in adults with bruxism: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1795-1801. doi: 10.1016/j.jbmt.2024.10.032. Epub 2024 Oct 16. | |
| 39510242 | Derived |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Occlusal splint | Device | In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night. |
|
| baseline, 3 and 6 months |
| Chisini LA, Pires ALC, Poletto-Neto V, Damian MF, Luz MS, Loomans B, Pereira-Cenci T. Occlusal splint or botulinum toxin-a for jaw muscle pain treatment in probable sleep bruxism: A randomized controlled trial. J Dent. 2024 Dec;151:105439. doi: 10.1016/j.jdent.2024.105439. Epub 2024 Nov 5. |