Temporomandibular Joint DysfunctionPhase 4NCT01524913
A Double Blind Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint (TMJ) Dysfunction
A Phase 4 study testing Hyaluronic acid, Corticosteroid and Lactated Ringers in people with Temporomandibular Joint Dysfunction and Pain, run by Emory University at 5 sites in United States.
Trial summary
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction, Pain, Arthrocentesis
- What is being tested?
- Hyaluronic acid, Corticosteroid and Lactated Ringers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to Apr 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- arthralgia of one or both temporomandibular joints
- Wilkes II to IV internal derangement of the symptomatic joint OR
- limited opening of <35 mm
Who cannot join
- myofascial pain as the primary source of pain
- cervical pain as the primary source of pain
- systemic arthropathy
- fibromyalgia
- use of NSAIDS within 48 hours
- allergy to study medications
Show all 10Show fewer
- edentulous subjects
- pregnancy or breast feeding
- current physical therapy, muscle relaxants or antiseizure medications
- current use of a splint issued within last 12 weeks
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University
Atlanta, Georgia, 30322
University of Cinncinati
Cinncinati, Ohio, 45219
University California Los Angeles
Los Angeles, California, 90024
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences University
Portland, Oregon, 97239
About this study
Official title: A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.
The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
Read the detailed description
This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
- Conditions
- Temporomandibular Joint Dysfunction, Pain, Arthrocentesis
- Being tested
- Hyaluronic acid, Corticosteroid, Lactated Ringers
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
1 cc hyalgan to be injected into superior joint space
CorticosteroidDrug
1cc celestone (6 mg/cc) will be injected into the joint space
Lactated RingersDrug
1 cc lactated ringers solution will be injected into the joint space
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Not described Receives: Drug: Hyaluronic acid |
| Corticosteroid | Active comparator | Not described Receives: Drug: Corticosteroid |
| Saline | Placebo comparator | Not described Receives: Drug: Lactated Ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Between Baseline and Month 1 Scores
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
Measured: Baseline (preoperation), Month 1
Secondary outcomes (3)
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.
Measured: Baseline (preoperation), Month 1, Month 3
Jaw Function Limitation Scale (JFLS) Score
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Measured: Month 1
Jaw Function Limitation Scale (JFLS) Score
The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of "no" are scored as "0" and responses of "yes" are scored as "1". The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8).
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Oregon Health and Science University, University of Minnesota, University of Cincinnati, University of Pennsylvania
- Responsible party
- Principal investigator, Gary F Bouloux MD, DDS, MDSc, FRACDS, FRACDS, Emory University
- Investigators
- Gary F Bouloux, MD, DDS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524913
- Sponsor's protocol ID
- IRB00018682
- Other IDs
- Arthrocentesis
- Status last verified
- Mar 2017
- First submitted
- 29 Jan 2012
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1. J Oral Maxillofac Surg. 2017 Jan;75(1):52-62. doi: 10.1016/j.joms.2016.08.006. Epub 2016 Aug 20.
PubMed 27632069Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2. J Oral Maxillofac Surg. 2017 Jan;75(1):63-72. doi: 10.1016/j.joms.2016.08.008. Epub 2016 Aug 20.
PubMed 27632067
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Study Comparing Hyaluronic Acid, Corticosteroid and Placebo During Arthrocentesis for Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT01524913
- Acronym / sponsor ID
- IRB00018682
- Conditions
- Temporomandibular Joint Dysfunction, Pain, Arthrocentesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Oregon Health and Science University, University of Minnesota, University of Cincinnati, University of Pennsylvania
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the administration of hyaluronic acid or corticosteroid during arthrocentesis of the temporomandibular joint provides additional pain relief and improved function.
The overall hypothesis for the study is that hyalgan will result in a 30% reduction in the mean visual analogue scale (VAS) at one month when compared to celestone and placebo.
Detailed description
This study will enroll patients with temporomandibular joint dysfunction who are deemed appropriate candidates for irrigation of their jaw joints secondary to pain or limited opening. At the completion of the joint irrigation subjects will be injected by one of three different products to determine if the additional injection results in a further decrease in jaw joint pain and improved opening. Subjects will be followed for 3 months. Those who do not show improvement may be candidates for additional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Drug: Hyaluronic acid |
| Corticosteroid | Active comparator | Drug: Corticosteroid |
| Saline | Placebo comparator | Drug: Lactated Ringers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age greater than 18 years
- arthralgia of one or both temporomandibular joints
- Wilkes II to IV internal derangement of the symptomatic joint OR
- limited opening of <35 mm
Key exclusion criteria (10 listed)
- myofascial pain as the primary source of pain
- systemic arthropathy
- fibromyalgia
- use of NSAIDS within 48 hours
- allergy to study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid1 cc hyalgan to be injected into superior joint space | Drug | Hyaluronic acid |
| Corticosteroid1cc celestone (6 mg/cc) will be injected into the joint space | Drug | Corticosteroid |
| Lactated Ringers1 cc lactated ringers solution will be injected into the joint space | Drug | Saline |
Primary outcome
Change in Pain Between Baseline and Month 1 Scores
Time frame: Baseline (preoperation), Month 1
The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.
3 secondary outcomes
Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3
Time frame: Baseline (preoperation), Month 1, Month 3
Jaw Function Limitation Scale (JFLS) Score
Time frame: Month 1
Jaw Function Limitation Scale (JFLS) Score
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27632069Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short-Term Reduction of Temporomandibular Joint Pain After Arthrocentesis? Part 1. J Oral Maxillofac Surg. 2017 Jan;75(1):52-62. doi: 10.1016/j.joms.2016.08.006. Epub 2016 Aug 20.
- Results publication: PubMed 27632067Bouloux GF, Chou J, Krishnan D, Aghaloo T, Kahenasa N, Smith JA, Giannakopoulos H. Is Hyaluronic Acid or Corticosteroid Superior to Lactated Ringer Solution in the Short Term for Improving Function and Quality of Life After Arthrocentesis? Part 2. J Oral Maxillofac Surg. 2017 Jan;75(1):63-72. doi: 10.1016/j.joms.2016.08.008. Epub 2016 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary F Bouloux, MD, DDS principal investigator
Emory University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid, Corticosteroid and Lactated Ringers in people with Temporomandibular Joint Dysfunction and Pain, run by Emory University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Between Baseline and Month 1 Scores (time frame: Baseline (preoperation), Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01524913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.