Botox vs Occlusal Splint for Masseter Pain

Pain, Face Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456154
• Other study ID #: PPGO022
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2018
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2021
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Pain, Face

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas	Pelotas	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Masticatory muscle pain	VAS will be used to assess decrease of pain	baseline, 3 and 6 months
Secondary	Oral health related quality of life	OHIP 14 questionnaire will be applied	baseline, 3 and 6 months
Secondary	Cervical Position	Modifications of cervical vertebral column position will be assessed	baseline, 3 and 6 months