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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 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.

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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.

Conditions Studied

Pain

Interventions

  • DRUG Lactated Ringers
  • DRUG Triamcinolone hexacetonide

Study Locations (1)

Florida

  • University of Florida College of Dentistry - Gainesville

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2013-03
Est. Completion 2019-01-24
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT01770912

The ClinicalTrials.gov registry entry for NCT01770912 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.