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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03456154

Enrollment

Registered

2018-03-07

Start date

2018-03-15

Completion date

2021-03-01

Last updated

2021-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Face

Brief 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.

Interventions

DRUGBotox Injectable Product

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

DEVICEOcclusal splint

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Oral health related quality of life	baseline, 3 and 6 months	OHIP 14 questionnaire will be applied
Cervical Position	baseline, 3 and 6 months	Modifications of cervical vertebral column position will be assessed

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026