TMJ Internal DerangementNCT01903512
Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments
An observational study of TMJ Internal Derangement, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ). Read more about this study
- Who is it for?
- Ages 25 to 62 years
- Conditions the study is for
- TMJ Internal Derangement
- What is being tested?
- TMJ arthrocentesis
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2010to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 62 years
- All sexes
- No healthy volunteers
- Adult
Study population: A total of 30 patients with TMJ internal derangement and pain with history of failed conservative management were selected. 70% had anteriorly displaced discs (AD), and 30 complained of other disorders (osteophytes, signs of soft tissues inflammmation, TMJ structure alterations).
Who may be able to join
- TMJ pain
- TMJ noises and click
- history of unsuccessful conservative management (NSAID and occlusal bite)
- occlusal bite still present
Who cannot join
- degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
- history of condylar fractures or previous TMJ trauma
- TMJ surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).
Read the detailed description
This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.
- Conditions
- TMJ Internal Derangement
- Being tested
- TMJ arthrocentesis
- Keywords
- TMJ arthrocentesis, internal derangement, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ arthrocentesisProcedure or surgery
lavage of the superior TMJ space with saline and sodium hyaluronate (SH)
| Study group | Role | What they receive |
|---|---|---|
| arthrocentesis in TMJ internal derangement | 30 patients with TMJ internal derangement and pain with history of failed conservative management. Receives: Procedure: TMJ arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain decrease
Patients were followed up for 1 year. The mean pre-operative pain, using visual analog scale, showed an average decrease of 6.7 at 1 year.
Measured: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
increase in the mouth opening
The mean maximum mouth opening(MMO) pre-operatively was 15,8 mm and increased to 34 mm immediately following arthrocentesis which increased by 0.5-1 mm at every month followup with mean MMO of 39,4 mm at 6 months. Thereafter it remained consistent till 1 year. The mean increase in the mouth opening at 1 year was 23,6 mm
Measured: Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
TMJ click and noises reduction
At the end of 1 year, (75%) patients stated no evidence of clicking.
Measured: Baseline (preop), 12 months (postop)
Secondary outcomes (1)
number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.
40% of subjects who showed clear signs of inflammation showed significant improvement, in 30% with structural alterations was evident the absence of intra-articular adhesions and debris, in 30% with internal derangement did not appear any radiographic change.
Measured: Baseline (preop)- 60 days postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TMJ Internal DerangementStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Mario Meloni, Università degli Studi di Sassari
- Investigators
- Silvio M Meloni, assist prof, Principal investigator, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903512
- Sponsor's protocol ID
- IT010713
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
De Riu G, Stimolo M, Meloni SM, Soma D, Pisano M, Sembronio S, Tullio A. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study. Int J Dent. 2013;2013:790648. doi: 10.1155/2013/790648. Epub 2013 Nov 11.
PubMed 24319462
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrocentesis and Temporomandibular Joint Disorders a Conservative Alternative to Surgical Treatments
- ClinicalTrials.gov ID
- NCT01903512
- Acronym / sponsor ID
- IT010713
- Conditions
- TMJ Internal Derangement
- Keywords
- TMJ arthrocentesis, internal derangement, conservative treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of arthrocentesis in the treatment of internal derangement of the temporomandibular joint (TMJ).
Detailed description
This work was designed as a prospective case series clinical study. Patients imaging was evaluated with Cone-Beam Computed Tomography and Nuclear Magnetic Resonance at the beginning of the treatment and after the last arthrocentesis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arthrocentesis in TMJ internal derangement | – | Procedure: TMJ arthrocentesis30 patients with TMJ internal derangement and pain with history of failed conservative management. |
Who may qualify
- Ages
- 25 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 30 patients with TMJ internal derangement and pain with history of failed conservative management were selected. 70% had anteriorly displaced discs (AD), and 30 complained of other disorders (osteophytes, signs of soft tissues inflammmation, TMJ structure alterations).
Key inclusion criteria (4 listed)
- TMJ pain
- TMJ noises and click
- history of unsuccessful conservative management (NSAID and occlusal bite)
- occlusal bite still present
Key exclusion criteria (3 listed)
- degenerative joint disease (such as osteoarthritis, rheumatoid arthritis etc.)
- history of condylar fractures or previous TMJ trauma
- TMJ surgery
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 |
|---|---|---|
| TMJ arthrocentesislavage of the superior TMJ space with saline and sodium hyaluronate (SH) | Procedure or surgery | arthrocentesis in TMJ internal derangement |
Primary outcome
Pain decrease
Time frame: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
Patients were followed up for 1 year. The mean pre-operative pain, using visual analog scale, showed an average decrease of 6.7 at 1 year.
increase in the mouth opening
Time frame: Baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)
The mean maximum mouth opening(MMO) pre-operatively was 15,8 mm and increased to 34 mm immediately following arthrocentesis which increased by 0.5-1 mm at every month followup with mean MMO of 39,4 mm at 6 months. Thereafter it remained consistent till 1 year. The mean increase in the mouth opening at 1 year was 23,6 mm
TMJ click and noises reduction
Time frame: Baseline (preop), 12 months (postop)
At the end of 1 year, (75%) patients stated no evidence of clicking.
1 secondary outcome
number of subjects showing signs of TMJ inflammation or structural alterations at Magnetic Resonance Imaging and Cone Beam Computerized Tomography pre- and postop.
Time frame: Baseline (preop)- 60 days postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Derived from this study: PubMed 24319462De Riu G, Stimolo M, Meloni SM, Soma D, Pisano M, Sembronio S, Tullio A. Arthrocentesis and temporomandibular joint disorders: clinical and radiological results of a prospective study. Int J Dent. 2013;2013:790648. doi: 10.1155/2013/790648. Epub 2013 Nov 11.
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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.
Silvio M Meloni, assist prof principal investigator
Università degli Studi di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TMJ Internal Derangement, run by Università degli Studi di Sassari at 1 site in Italy.
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 3 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 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain decrease (time frame: baseline (preop), 1 week, 1 month, 2 months, 6 months, 12 months (postop)). The study lists 3 primary outcomes in all. 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 NCT01903512, which also lists 1 linked publication.
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 19 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.