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NCT Number: NCT07445191

Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial

This study aims to clinically evaluate the efficacy of trigger points using active drug mix (Triamcinolone with lidocaine) on relief of myofascial pain of jaw muscle.

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Key information

Conditions

TMJ Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age more than or equal 18 years
  • Both sexes
  • Patients' willingness to follow instructions

Exclusion criteria

  • Patients who will be using any medications to reduce the pain and/or have any effect on the skeletal muscle
  • Clinical conditions such as pregnancy
  • Medical problems that may interfere with the procedures such as bleeding disorders
  • Cognitive impairment or exhibited inadequate cooperation
  • Patients will be receiving physical therapy or wearing occlusal splint in the same period of the research

Treatment and study plan

Saline

Drug

Patients will take 1 ml of lidocaine 2%

Triamcinolone with lidocaine

Drug

Patients will take 1 ml of active drug mix (1/4 ml of Triamcinolone and 3/4 ml of lidocaine)

Lidocaine

Drug

Patients will take 1 ml lidocaine 2%

Primary outcomes

  1. current pain intensity

    Time frame: 1 week , 1 month , 3 months after treatment

    • Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on visual analogue scale (VAS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had

Secondary outcomes

  1. maximum mouth opening

    Time frame: 1 week , 1 month , 3 months after treatment

    • Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler.
    • The postoperative demand for analgesics will be evaluated by recording the number of the analgesic's intake.
    • Patient satisfaction.
    • Pressure pain threshold (PPT).

    Data will be collected preoperatively, pain will be measured immediately after the treatment, as well as one week, one month, and 3 months after the end of the treatment sessions

  2. post operative demands for analgesics

    Time frame: 1 week , 1 month , 3 months after treatment

    measuring unit number

  3. patient satisfaction

    Time frame: 1 week , 1 month , 3 months after treatment

    measured by likert scale

  4. pressure pain threshold (PPT)

    Time frame: 1 week , 1 month , 3 months after treatment

    measuresd by algometer

Study contacts

Contact information is provided by the study sponsor or research team.

Ammar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree

CONTACT

[email protected]

0103052078

Hamida Refai Hasanien Hasanien professor, phd

CONTACT

01013052078

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Clinical Assessment of The Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

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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