Botox vs Occlusal Splint for Masseter Pain

Federal University of Pelotas

Status and phase: Completed; Phase 4

Conditions: Pain, Face

Treatments: Device: Occlusal splint; Drug: Botox Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT03456154

PPGO022

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Botox

Experimental group

Description:

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.

Treatment:

Drug: Botox Injectable Product

Occlusal splint

Active Comparator group

Description:

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.

Treatment:

Device: Occlusal splint