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

NCT07445191 | Not Yet Recruiting Phase 2

• 1 other identifier: injection of masseter muscle
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

TMJ Pain

Keywords

masseter muscle

Outcome Measures

Primary Outcomes (1)

• current pain intensity

  • 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

  1 week , 1 month , 3 months after treatment

Secondary Outcomes (4)

• maximum mouth opening

  1 week , 1 month , 3 months after treatment

• post operative demands for analgesics

  1 week , 1 month , 3 months after treatment

• patient satisfaction

  1 week , 1 month , 3 months after treatment

• pressure pain threshold (PPT)

  1 week , 1 month , 3 months after treatment

Study Arms (3)

Saline

ACTIVE COMPARATOR

Drug: Saline

Triamcinolone with lidocaine

EXPERIMENTAL

Drug: Triamcinolone with lidocaine

Lidocaine

EXPERIMENTAL

Drug: Lidocaine

Interventions

Saline DRUG

Patients will take 1 ml of lidocaine 2%

Saline

Triamcinolone with lidocaine DRUG

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

Triamcinolone with lidocaine

Lidocaine DRUG

Patients will take 1 ml lidocaine 2%

Lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Sodium Chloride; Triamcinolone; Lidocaine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hamida Refai Hasanien Hasanien Hamida Refai Hasanien, phd

  cair university

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

0103052078; prof.hamidarefaee@gmail.com

Hamida Refai Hasanien Hasanien professor, phd

CONTACT

01013052078

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AAMAHawbani

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share