NCT07630909

Brief Summary

Temporomandibular joint disorders represent a complex and heterogeneous group of musculoskeletal conditions affecting the temporomandibular joint,masticatory muscles, and associated structures, frequently manifesting as chronic orofacial pain. Temporomandibular joint (TMJ) disorders encompass a group of conditions affecting the jaw joint and associated musculature, leading to pain, impaired function, and a diminished quality of life. These disorders arise from various etiologies, including trauma,degenerative conditions such as osteoarthritis, and systemic inflammatory diseases, emphasizing their multifactorial nature. Although the mechanism of action of mesotherapy in TMJ disorders involves delivering anti-inflammatory and analgesic agents directly to the affected area,the literature reveals a significant research gap regarding its efficacy and longterm benefits.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

5 days

First QC Date

April 1, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

MesotherapyMyofascial Pain SyndromeTrigger PointsIntradermal InjectionNon-invasive Treatment

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their pain before the first treatment and after completion of the 4-week treatment period.

    From 4 weeks to 3 months

Secondary Outcomes (1)

  • Change in Maximum Mouth Opening (MMO)

    Baseline and 4 weeks after treatment initiation

Other Outcomes (2)

  • Change in Quality-of-Life (QoL)

    Baseline, 4 weeks, and 3 months

  • Patient Satisfaction

    End of treatment (4 weeks) and 3-month follow-up

Study Arms (2)

Mesotherapy Group

EXPERIMENTAL

Participants in this group will receive mesotherapy injections into the affected muscle areas following a standardized protocol. Small doses of mixed medications (such as lidocaine and anti-inflammatory agents) will be injected intradermally around the trigger points once weekly for 4 weeks. The aim is to achieve localized pain relief, improved microcirculation, and better muscle function.

Procedure: MesotherapyProcedure: trigger point injection

Trigger Point Injection Group

ACTIVE COMPARATOR

Participants in this group will receive conventional trigger point injections (TPI) using a local anesthetic directly into the identified trigger points. The injections will be administered once weekly for 4 weeks to relieve muscle tension and pain.

Procedure: MesotherapyProcedure: trigger point injection

Interventions

MesotherapyPROCEDURE

Mesotherapy involves the administration of very small doses of medications into the superficial layer of the skin over the painful muscle area. The injected solution typically contains lidocaine and anti-inflammatory agents. In this study, mesotherapy will be performed once weekly for four weeks using multiple superficial intradermal microinjections around the trigger points to reduce pain, improve local blood flow, and restore muscle function

Mesotherapy GroupTrigger Point Injection Group

Trigger point injection (TPI) consists of the direct intramuscular injection of a local anesthetic, such as lidocaine, hydrocortisone and ketolac into identified myofascial trigger points. The procedure aims to deactivate painful trigger points, relieve muscle spasm, and reduce referred pain. In this study, injections will be administered once weekly for four weeks using a standardized technique to ensure consistency and safety

Mesotherapy GroupTrigger Point Injection Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients between 18 - 60 years.
  • Patients who had a Diagnosis of TMD, with chronic pain, muscle spasms, myofascial pain syndrome lasting at least 3 months, and challenges while chewing.
  • Patients who have difficulty opening their mouths, cases where conservative treatment methods (physical, medical, or appliances) have failed.
  • Patients who have Bruxism -

You may not qualify if:

  • Systemic Diseases such as uncontrolled Diabetes, uncontrolled hypertension disorders of coagulation (hemophiliacs, undergoing therapy with anticoagulants or antiplatelet agents, and cancer patients undergoing chemotherapy.
  • Patients with a history of Muscular dystrophies, Myasthenia Gravis, Polymyositis, Rheumatoid arthritis, Hypothyroidism, and Sarcoidosis
  • Patients with active Infections around the injection site.
  • Females who are pregnant or breastfeeding are excluded.
  • A patient who had a history of severe mental health disorders or neurological conditions affecting pain perception or compliance.
  • Patients with allergies to the components used in mesotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Oral and Dental Medicine, Future University in Egypt

New Cairo, Cairo Governorate, 4740011, Egypt

Location

Related Publications (1)

  • Cruz AP, Oliveira A, Martins J, Santos P, et al. Effectiveness of mesotherapy on temporomandibular joint disorders. Journal of Physical Science and Application. 2015;5(4):249-254.

    RESULT

Related Links

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Mesotherapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCosmetic TechniquesInjections, SubcutaneousInjectionsDrug Administration RoutesDrug Therapy

Study Officials

  • Waleed Fathy Ali Esmael, Professor

    Associate Professor of Oral & Maxillofacial Surgery, Future University in Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher of Oral and Dental Medicine

Study Record Dates

First Submitted

April 1, 2026

First Posted

June 5, 2026

Study Start

September 2, 2025

Primary Completion

September 7, 2025

Study Completion

September 9, 2025

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations