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
Among 14 studies in Facial Pain with a site in Brazil — 2 open to participants now, 2 under way, none of them phase 3. Facial Pain · Brazil.
Among the 14 studies in Facial Pain with a site in Brazil, this one is the 5th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is the only one in phase 4, and was the 11th registered.
182 studies on the registry are indexed under Facial Pain; 61 are open to participants now.
Browse Facial Pain studies →2 of the 14 studies in Facial Pain with a site in Brazil are open now. Recruiting first, the newest first:
Associação Pan-Americana Multidisciplinar de Endocanabinologia · Sites in Brazil
Ages 45–80 · Women only
Flávio Magno Gonçalves · Sites in Brazil
Ages 18–80 · Healthy volunteers
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 30 Facial Pain studies recruiting now, 16 (53%) set no upper age limit and 10 (33%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
This study's enrollment of 60 is above the median of 50 across 132 interventional studies indexed under Facial Pain.
Median enrollment 45 across the 13 interventional studies, 100 across the 1 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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1 of 14 have an industry lead sponsor. The 10 most frequent:
Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Federal University of Pelotas has 1 study filed under Facial Pain — fewer than ten, so there is no comparison to draw.
2 of the studies in Facial Pain with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07706153Flávio Magno GonçalvesComparative Analysis of Dry Needling Techniques for Orofacial Myofascial Pain | 2026-12-01 |
| NCT07783295Associação Pan-Americana Multidisciplinar de EndocanabinologiaFull-Spectrum Cannabis Extract for Chronic Pain and Bone Health Biomarkers in Women | 2027-09-01 |
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Among the 14 studies in Facial Pain with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Ran from Mar 2018 to primary completion in Jan 2021, 34 months.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Botulinum toxin type A
Federal University of Pelotas