A Phase 4 interventional study of Botox Injectable Product and Occlusal splint in Pain, Face, sponsored by Federal University of Pelotas. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Federal University of Pelotas · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
60u will be used at 3 sites of masseter muscle, on each side of the face
In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.
Masticatory muscle pain
VAS will be used to assess decrease of pain
Time frame: baseline, 3 and 6 months
Oral health related quality of life
OHIP 14 questionnaire will be applied
Time frame: baseline, 3 and 6 months
Cervical Position
Modifications of cervical vertebral column position will be assessed
Time frame: baseline, 3 and 6 months
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Federal University of Pelotas