Botox vs Occlusal Splint for Masseter Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2021-03-01

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.

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Detailed Description

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Conditions

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Pain, Face

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Botox

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.

Group Type EXPERIMENTAL

Botox Injectable Product

Intervention Type DRUG

60u will be used at 3 sites of masseter muscle, on each side of the face

Occlusal splint

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.

Group Type ACTIVE_COMPARATOR

Occlusal splint

Intervention Type DEVICE

In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

Interventions

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Botox Injectable Product

60u will be used at 3 sites of masseter muscle, on each side of the face

Intervention Type DRUG

Occlusal splint

In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes