Botox vs Occlusal Splint for Masseter Pain

Phase 4

Completed

• Conditions: Pain, Face
• Interventions: Drug: Botox Injectable Product; Device: Occlusal splint

• Registration Number: NCT03456154
• Lead Sponsor: Federal University of Pelotas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-07
• Study Start: 2018-03-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-03-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox	Botox Injectable Product	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.
Occlusal splint	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.

Primary Outcome Measures

Name	Time	Method
Masticatory muscle pain	baseline, 3 and 6 months	VAS will be used to assess decrease of pain

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Pelotas; 🇧🇷 Pelotas, Rio Grande Do Sul, Brazil