Botox vs Occlusal Splint for Masseter Pain

May 18, 2021 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96015560
        • Federal University of Pelotas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Botox Injectable Product
60u will be used at 3 sites of masseter muscle, on each side of the face
Active Comparator: 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.
Device: Occlusal splint
In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Pelotas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

January 15, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPGO022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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