NCT03456154

Botox vs Occlusal Splint for Masseter Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pain, Face

Interventions

Type	Name	Description
DRUG	Botox Injectable Product	60u will be used at 3 sites of masseter muscle, on each side of the face
DEVICE	Occlusal splint	In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

Timeline

• Start date: 2018-03-15
• Primary completion: 2021-01-15
• Completion: 2021-03-01
• First posted: 2018-03-07
• Last updated: 2021-05-20

Locations

1 site across 1 country: Brazil