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Botox vs Occlusal Splint for Masseter Pain

Primary Purpose

Pain, Face

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Botox Injectable Product
Occlusal splint
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Face

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Pelotas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botox

Occlusal splint

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Masticatory muscle pain
VAS will be used to assess decrease of pain

Secondary Outcome Measures

Oral health related quality of life
OHIP 14 questionnaire will be applied
Cervical Position
Modifications of cervical vertebral column position will be assessed

Full Information

First Posted
February 28, 2018
Last Updated
May 18, 2021
Sponsor
Federal University of Pelotas
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1. Study Identification

Unique Protocol Identification Number
NCT03456154
Brief Title
Botox vs Occlusal Splint for Masseter Pain
Official Title
Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Face

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Experimental
Arm Description
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.
Arm Title
Occlusal splint
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botox Injectable Product
Intervention Description
60u will be used at 3 sites of masseter muscle, on each side of the face
Intervention Type
Device
Intervention Name(s)
Occlusal splint
Intervention Description
In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.
Primary Outcome Measure Information:
Title
Masticatory muscle pain
Description
VAS will be used to assess decrease of pain
Time Frame
baseline, 3 and 6 months
Secondary Outcome Measure Information:
Title
Oral health related quality of life
Description
OHIP 14 questionnaire will be applied
Time Frame
baseline, 3 and 6 months
Title
Cervical Position
Description
Modifications of cervical vertebral column position will be assessed
Time Frame
baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Federal University of Pelotas
City
Pelotas
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96015560
Country
Brazil

12. IPD Sharing Statement

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Botox vs Occlusal Splint for Masseter Pain

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