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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03456154
Other study ID # PPGO022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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