Botox vs Occlusal Splint for Masseter Pain
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|ClinicalTrials.gov Identifier: NCT03456154|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Face||Drug: Botox Injectable Product Device: Occlusal splint||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Use of Botox Versus Conventional Treatment for Pain Decrease of Muscular Pain: a Randomized Controlled Trial|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||August 15, 2018|
|Estimated Study Completion Date :||March 1, 2019|
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.
- Pain [ Time Frame: baseline, 3 and 6 months ]VAS will be used to assess decrease of pain
- Oral health related quality of life [ Time Frame: baseline, 3 and 6 months ]OHIP 14 questionnaire will be applied
- Cervical Position [ Time Frame: baseline, 3 and 6 months ]Modifications of cervical vertebral column position will be assessed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456154
|Federal University of Pelotas||Recruiting|
|Pelotas, Rio Grande Do Sul, Brazil, 96015560|
|Contact: Maximiliano Cenci, PhD 555332256741 ext 135 firstname.lastname@example.org|
|Contact: Tatiana Cenci, PhD 5553 email@example.com|