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Completed

NCT Number: NCT01770912

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 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.

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Key information

Conditions

Pain Facial Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

About this study

Temporomandibular joint disorders are common and poorly understood in terms of etiology and pathogenesis. These disorders are multifactorial in origin including physical and psychosocial aspects; however, there is little understanding as to how much each of these components are associated with a particular diagnosis and subsequent treatment outcome of temporomandibular joint disorders. There is also a paucity of information regarding the relative effectiveness of different therapies for the treatment of patients with temporomandibular joint disorders. The identification of the least invasive and most efficacious therapy is vital to proper management of these patients with temporomandibular joint pain.

Patients enrolled into the study will be examined and treated at the Department of Oral and Maxillofacial Surgery. At the first appointment, they will be examined following standard procedures to determine if they would potentially benefit from the TMJ arthrocentesis procedure. If the patient meets the inclusion criteria for the study and with their informed consent, they will be required to complete a questionnaire about their physical and pain symptoms and undergo a standardized clinical exam. At the next appointment, the patients will undergo the standard clinical protocol for TMJ arthrocentesis with either only normal saline or normal saline with adjunctive steroids (triamcinolone hexacetonide). Follow-up appointments will be at 2 weeks, 6 weeks and 12 weeks where the pain VAS and clinical exams will be completed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • 18-80 years of age
  • TMJ arthralgia
  • Masticatory myalgia
  • TMJ sounds
  • History of at least 6 weeks use of occlusal appliance therapy

Exclusion criteria

  • Contraindication to sedation including pregnancy or medical history
  • History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy
  • History of steroidal injection into TMJ
  • History of trauma to TMJ
  • TMJ pain longer than 3 years
  • History of narcotic drug use on a scheduled basis
  • Current active infection

Treatment and study plan

Lactated Ringers

Drug

Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.

Triamcinolone hexacetonide

Drug

1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.

Other names: Aristospan, steroid

Primary outcomes

  1. Change From Pre-Treatment in TMJ Loading Pain Rating at 12 Weeks

    Time frame: 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 outcomes

  1. Change From Pre-Treatment in TMJ Loading Pain Rating at 2 Weeks

    Time frame: Baseline and 2 weeks post-treatment

    TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

  2. Change From Pre-Treatment in TMJ Loading Pain Rating at 6 Weeks

    Time frame: Baseline and 6 weeks post-treatment

    TMJ loading pain is evaluated using ordinal scale ratings of 0-3 (none, mild, moderate, severe pain intensity).

  3. Change From Pre-Treatment in Mandibular Range of Motion Without Pain at 2 Weeks

    Time frame: 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.

  4. Change From Pre-Treatment in Mandibular Range of Motion at 6 Weeks

    Time frame: 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.

  5. Change From Pre-Treatment in Mandibular Range of Pain-Free Motion at 12 Weeks

    Time frame: 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.

  6. Change From Pre-Treatment Palpable Muscle Tenderness at 2 Weeks

    Time frame: 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.

  7. Change From Pre-Treatment Palpable Muscle Tenderness at 6 Weeks

    Time frame: 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.

  8. Change From Pre-Treatment Palpable Muscle Tenderness at 12 Weeks

    Time frame: 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.

  9. Number of Participants With Change From Pre-Treatment Joint Sounds in 2 Weeks

    Time frame: 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.

  10. Number of Participants With Change From Pre-Treatment Joint Sounds in 6 Weeks

    Time frame: Baseline and 6 weeks post-treatment

    Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.

  11. Number of Participants With Change From Pre-Treatment Joint Sounds in 12 Weeks

    Time frame: Baseline and 12 weeks post-treatment

    Opening and closing sounds (click, course crepitus, fine crepitus) detected by palpation on left, right or both sides of face.

  12. Change From Pre-Treatment Functional Pain (Chewing) at 2 Weeks

    Time frame: Baseline and 2 weeks post-treatment

    Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".

  13. Change From Pre-Treatment Functional Pain (Chewing) at 6 Weeks

    Time frame: Baseline and 6 weeks post-treatment

    Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".

  14. Change From Pre-Treatment Functional Pain (Chewing) at 12 Weeks

    Time frame: Baseline and 12 weeks post-treatment

    Pain is assessed for average chewing pain intensity using a 100 mm visual analog scale with 0 representing "no pain" and 100 representing "the most intense chewing pain imaginable".

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

A Randomized, Double-Blind Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2013
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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