Botox vs Occlusal Splint for Masseter Pain

Study Overview
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Brief Summary
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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.

Official Title
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Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial

Conditions
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Pain, Face

Intervention / Treatment
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* Drug: Botox Injectable Product
* Device: Occlusal splint


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox<br>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. | Drug: Botox Injectable Product<br>* 60u will be used at 3 sites of masseter muscle, on each side of the face<br>|
| Active Comparator: Occlusal splint<br>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. | Device: Occlusal splint<br>* In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Masticatory muscle pain | VAS will be used to assess decrease of pain | baseline, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | baseline, 3 and 6 months |