Trial · NCT01770912
Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
NCT01770912, Phase 2, Completed, University of Florida; results first posted 2020-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management. Trials, record NCT01770912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01770912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Steroid Supplementation After TMJ Rinsing for Pain Management
- NCT number
- NCT01770912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Pain
- Interventions
- Lactated Ringers, Triamcinolone hexacetonide
- First posted
- 2013-01-18
- Last updated
- 2020-10-08
- Results first posted
- 2020-10-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | Baseline and 12 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
| Secondary | Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | Baseline and 2 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
| Secondary | Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | Baseline and 6 weeks post-treatment | TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity). |
| Secondary | Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | Baseline and 2 weeks post-treatment | Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. |
| Secondary | Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | Baseline and 6 weeks post-treatment | Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. |
| Secondary | Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | Baseline and 12 weeks post-treatment | Mandibular range of motion is measured in millimeters (mm) of vertical opening between the upper and lower central incisors plus vertical overlap of the incisors. These measures are made for jaw unassisted opening without pain, maximum unassisted opening and maximum assisted opening. Horizontal mandibular range of motion is measured in millimeters (mm) assessed for maximal right and left mandibular lateral movements and mandibular protrusion. A positive value represents an improvement (or larger range of motion) in mandibular opening/lateral movement. |
| Secondary | Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | Baseline and 2 weeks post-treatment | Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. |
| Secondary | Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | Baseline and 6 weeks post-treatment | Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. |
| Secondary | Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | Baseline and 12 weeks post-treatment | Palpable muscle tenderness of masticatory muscles using ordinal ratings of 0-3 (none, mild, moderate, severe pain to palpation) are summed. A standardized muscle palpation pressure is used at specific locations on each side of the face for a total of 20 locations. The range of possible scores is 0-60. The rating of each muscle palpation site is added for a composite muscle tenderness score. |
| Secondary | Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | Baseline and 2 weeks post-treatment | Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | Baseline and 12 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | Baseline and 2 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | Baseline and 6 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | Baseline and 2 weeks post-treatment | mm | MEAN | |
| SECONDARY | Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | Baseline and 6 weeks post-treatment | mm | MEAN | |
| SECONDARY | Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks | Baseline and 12 weeks post-treatment | mm | MEAN | |
| SECONDARY | Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks | Baseline and 2 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks | Baseline and 6 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks | Baseline and 12 weeks post-treatment | units on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | Baseline and 2 weeks post-treatment | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | Lactated Ringers | -1 | Full Range -2 to 0 | units on a scale | |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks | Triamcinolone Acetonide | -2 | Full Range -3 to 0 | units on a scale | |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | Lactated Ringers | -1 | Full Range -3 to 0 | units on a scale | |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks | Triamcinolone Acetonide | -2 | Full Range -3 to 0 | units on a scale | |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | Lactated Ringers | -1 | Full Range -2 to 2 | units on a scale | |
| Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks | Triamcinolone Acetonide | -2 | Full Range -3 to -1 | units on a scale | |
| Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | Lactated Ringers | 3.9 | Standard Error 2.4 | mm | |
| Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks | Triamcinolone Acetonide | 9.7 | Standard Error 2.6 | mm | |
| Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | Lactated Ringers | 6.9 | Standard Error 2.8 | mm | |
| Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks | Triamcinolone Acetonide | 7.4 | Standard Error 2.9 | mm |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lactated Ringers | 12 | |
| Overall Study | STARTED | Triamcinolone Acetonide | 12 | |
| Overall Study | COMPLETED | Lactated Ringers | 10 | |
| Overall Study | COMPLETED | Triamcinolone Acetonide | 12 | |
| Overall Study | NOT COMPLETED | Lactated Ringers | 2 | |
| Overall Study | NOT COMPLETED | Triamcinolone Acetonide | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lactated Ringers | 0 | 12 |
| Total, all-cause mortality | Triamcinolone Acetonide | 0 | 12 |
| Total, other adverse events | Lactated Ringers | 0 | 12 |
| Total, other adverse events | Triamcinolone Acetonide | 0 | 12 |
| Total, serious adverse events | Lactated Ringers | 0 | 12 |
| Total, serious adverse events | Triamcinolone Acetonide | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 1298767 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lactated Ringers vs Triamcinolone Acetonide: Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks | Trial comparisons |
| Lactated Ringers vs Triamcinolone Acetonide: deaths from any cause | Trial comparisons |
| Lactated Ringers vs Triamcinolone Acetonide: Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks | Trial comparisons |
| Lactated Ringers vs Triamcinolone Acetonide: Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks | Trial comparisons |
| Lactated Ringers vs Triamcinolone Acetonide: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01770912
GET https://conductscience.org/api/trials/v1/NCT01770912/results?page=2