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NCT01770912 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
A Phase 2 study of Pain, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01770912: Completed Phase 2 study of Pain, sponsored by University of Florida.
NCT01770912 is a Phase 2 study of Pain that has completed, run by University of Florida. The registered enrollment target is 24 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01770912, a Phase 2 study of Pain, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment. All procedures will be the same as if following normal TMJ arthrocentesis (rinsing) clinical care except that the patient will be randomly assigned to one of two groups: (1) TMJ rinsing followed by the injection of 1 cc (about ¼ of a teaspoon) of the same rinsing solution (this is the placebo) into the jaw joint; or (2) TMJ rinsing followed by the injection of 1 cc (about ¼ teaspoon) of a steroid (5 mg of triamcinolone hexacetonide) into the jaw joint. A pregnancy test (urine test) will be conducted on all women of child-bearing age to verify that the patient is not pregnant before the rinsing procedure. The patient will fill out a short questionnaire and have a short exam of the TMJ and jaw muscles at each appointment.
Primary Outcome
TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).
Conditions Studied
Interventions
- DRUG Lactated Ringers
- DRUG Triamcinolone hexacetonide
Study Locations (1)
Florida
- University of Florida College of Dentistry - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-03 |
| Est. Completion | 2019-01-24 |
| Phase | Phase 2 |
What the finished NCT01770912 record still lists
NCT01770912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Lactated Ringers is the first listed.
NCT01770912 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01770912 about?
NCT01770912 is a clinical study titled "Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management". The hypothesis to be tested is temporomandibular joint (TMJ) rinsing followed by steroid injection is more efficacious than a placebo injection based on standard pain and physical measures that are recorded before and after treatment. All procedures will be the same as if following normal TMJ arthr...
What is the current status of trial NCT01770912?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2013-03. Estimated completion is 2019-01-24.
What conditions does trial NCT01770912 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT01770912?
The interventions under investigation include: Lactated Ringers (DRUG), Triamcinolone hexacetonide (DRUG).
Who is sponsoring clinical trial NCT01770912?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01770912 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01770912's enrollment target sits among peer trials
24 325th of 374 higher than 42 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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