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Temporomandibular Joint Disc DisplacementPhase 4NCT04110587

Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy

A Phase 4 study testing Hyaluronic Acid, Temporomandibular Joint Arthroscopy and Antibiotic therapy in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disorders, run by Universidad Complutense de Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. A participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hyaluronic Acid, Temporomandibular Joint Arthroscopy and Antibiotic therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteSpain
Study dates
10 Dec 2013to 9 Jul 2019
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of temporomandibular joint internal derangements in Wilkes stages III and IV by magnetic resonance imaging
  • Limitation of maximum oral opening or duplication of joint pain by palpation
  • lack of response to conservative therapies

Who cannot join

  • Any degenerative systemic disease of muscular or joint involvement (rheumatoid arthritis, etc.)
  • Previous temporomandibular joint surgical treatment: arthrocentesis, arthroscopy or open surgery
  • Infection in Temporomandibular Joint or in puncture site
  • Hyaluronic acid or corticosteroids injection in Temporomandibular Joint in previous 6 months
  • Pregnant or breastfeeding women
  • Participants who refuse to complete the treatment or unavailable to complete the follow-up

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de La Princesa

    Madrid, 28006

Other trials in Spain

About this study

Official title: Hyaluronic Acid Evaluation as Adjuvant to Temporomandibular Joint Arthroscopy in Wilkes Stages

This study evaluates the addition of hyaluronic acid to temporomandibular joint arthroscopy in the treatment of internal derangements in adults. A participants group will receive temporomandibular joint arthroscopy plus hyaluronic acid, while the other group will receive temporomandibular joint arthroscopy. Hypothesis: hyaluronic acid as an adjunct in temporomandibular joint arthroscopic surgery provides additional benefits in clinical and radiological outcomes in temporomandibular joint internal derangements.

Being tested
Hyaluronic Acid, Temporomandibular Joint Arthroscopy, Antibiotic therapy, corticosteroid, Antiinflammatories
Keywords
hyaluronic acid, temporomandibular joint arthroscopy, internal derangements, disc displacement, temporomandibular disorders
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic AcidBiological

    Also called Sodium Hyaluronate

    1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .

  • Temporomandibular Joint ArthroscopyProcedure or surgery

    Lysis and Lavage

  • Antibiotic therapyDrug

    Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).

  • corticosteroidDrug

    Dexamethasone, 4 mg I.V. (Intraoperative)

  • AntiinflammatoriesDrug

    Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).

  • AnalgesicsDrug

    Metamizol 575 mg / 8h by mouth (Post-operatively)

  • Exercise programOther

    Home exercise program

Study groups in NCT04110587
Study groupRoleWhat they receive
arthroscopyPlacebo comparatorTemporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative.
Receives: Procedure: Temporomandibular Joint Arthroscopy; Drug: Antibiotic therapy; Drug: corticosteroid; Drug: Antiinflammatories; Drug: Analgesics; Other: Exercise program
arthroscopy plus hyaluronic AcidActive comparatorTemporomandibular joint arthroscopy is performed under general anesthesia by the same expert temporomandibular joint arthroscopy surgeon. Lysis and Lavage is performed in the upper joint space in all cases. Ringer's lactate is use as irrigation fluid. All participants receive Amoxicillin / Clavulanic Acid, 1g I.V. and Dexamethasone, 4 mg I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth; Diclofenac 100 mg / 12h / 5 days by mouth; and Metamizol 575 mg / 8h by mouth (Post-operatively). Soft diet and a home exercise program are implemented in all patients after 24 hours post-operative. An hyaluronic acid injection of 1 mL (Durolane®, 20 mg / mL, Zambon, Barcelona, Spain) at the end of arthroscopy that was only performed in this arm.
Receives: Biological: Hyaluronic Acid; Procedure: Temporomandibular Joint Arthroscopy; Drug: Antibiotic therapy; Drug: corticosteroid; Drug: Antiinflammatories; Drug: Analgesics; Other: Exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months

    Visual Analog Scale 0 to 10. Higher values represent a worse outcome.

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  2. Mean Change from Baseline in Maximal Oral Opening Scores (mm) at 3,6,9 and 12 Months

    measured from edge of upper central incisor to edge of lower antagonist incisor. Range scale 0 to 60 (mm). Higher values represent a better outcome.

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  3. Mean Change from Baseline in Oral Health Impact Profile-14 Spanish Version (OHIP-14sp) questionnaire Scores at 6 and 12 Months

    OHIP-14sp questionnaire total average score to measure Oral Health-Related Quality of Life. Range scale 0 to 56. Higher values represent a worse outcome. Total average score is calculated by adding the score of each question and dividing by 14

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 6, Month 12.

Secondary outcomes (16)

  1. Number of Participants with Treatment Related Adverse Events

    any adverse response to the intervention

    Measured: From intervention to end of study at 12 Months. During procedure or immediately after intervention, Month 3, Month 6, Month 9, Month 12.

  2. Symptoms Duration Mean (Months)

    symptoms duration mean reported by the participants

    Measured: At baseline

  3. Number of Participants with chondromalacia

    arthroscopic finding

    Measured: During intervention

  4. Number of Participants with synovitis

    arthroscopic finding

    Measured: During intervention

  5. Irrigation Volume Mean (cc)

    average irrigation fluid used during intervention

    Measured: During intervention

  6. Number of Participants with Occlusal Stabilization Splint

    stabilization splint use reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  7. Number of Participants with Osteophyte by magnetic resonance imaging

    radiographic finding in jaw condyle

    Measured: At baseline and Month 12.

  8. Number of Participants with joint surfaces flattening by magnetic resonance imaging

    radiographic finding in jaw condyle or temporal bone

    Measured: At baseline and Month 12

  9. Number of Participants with Subchondral Geode by magnetic resonance imaging

    radiographic finding in jaw condyle

    Measured: At baseline and Month 12

  10. Disc Position by magnetic resonance imaging

    No Displacement, Disc Displacement with Reduction, Disc Displacement without Reduction

    Measured: At baseline and Month 12

  11. Number of Participants with pain in masseter muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  12. Number of Participants with pain in Temporal muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  13. Number of Participants with pain in Medial Pterygoid Muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  14. Number of Participants with pain in digastric Muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  15. Number of Participants with pain in Genihyoid Muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

  16. Number of Participants with pain in Mylohyoid Muscle by digital palpation

    pain reported by the participant

    Measured: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start10 Dec 2013
  3. Primary completion9 Jul 2019
  4. Study completion9 Jul 2019

Resources

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04110587
Sponsor's protocol ID
DUROLANE2013
Status last verified
Sep 2019
First submitted
23 Sep 2019
Last updated
1 Oct 2019
Results posted
No
Individual data sharing
No

Publications

  • Montero-Martin J, Bravo-Perez M, Albaladejo-Martinez A, Hernandez-Martin LA, Rosel-Gallardo EM. Validation the Oral Health Impact Profile (OHIP-14sp) for adults in Spain. Med Oral Patol Oral Cir Bucal. 2009 Jan 1;14(1):E44-50.

    PubMed 19114956

  • Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

    PubMed 8193981

  • Shi Z, Guo C, Awad M. Hyaluronate for temporomandibular joint disorders. Cochrane Database Syst Rev. 2003;(1):CD002970. doi: 10.1002/14651858.CD002970.

    PubMed 12535445

  • Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. doi: 10.1001/archotol.1989.01860280067019.

    PubMed 2923691

  • Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.

    PubMed 32609918

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hyaluronic Acid, Temporomandibular Joint Arthroscopy and Antibiotic therapy in people with Temporomandibular Joint Disc Displacement and Temporomandibular Joint Disorders, run by Universidad Complutense de Madrid at 1 site in Spain.

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 3 inclusion and 6 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 1 Oct 2019. 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 Spain. 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?

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?

Mean Change from Baseline in Pain Scores on the Visual Analog Scale at 3,6,9 and 12 Months (time frame: From enrollment to end of study at 12 Months. Baseline, Month 3, Month 6, Month 9, Month 12.). 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 NCT04110587, which also lists 5 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 1 Oct 2019.

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