Pain, Face Clinical Trial
Official title:
Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
Verified date | May 2021 |
Source | Federal University of Pelotas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 1, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Between 18 and 70 years old; - at least 20 teeth in the mouth; - occlusal stability; - presenting pain in face muscles. Exclusion Criteria: - Angle's Class III - Kennedy's Class II or I removable partial denture wearer; - Complete denture wearer; - Individuals that have taken any anti inflammatory drugs in the last 3 months; - Individuals with temporomandibular joint disorders. |
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Pelotas | Pelotas | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Federal University of Pelotas |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Masticatory muscle pain | VAS will be used to assess decrease of pain | baseline, 3 and 6 months | |
Secondary | Oral health related quality of life | OHIP 14 questionnaire will be applied | baseline, 3 and 6 months | |
Secondary | Cervical Position | Modifications of cervical vertebral column position will be assessed | baseline, 3 and 6 months |
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