Peloid Therapy in Temporomandibular Joint Dysfunction

NCT07576582 | Recruiting DMC

• 1 other identifier: PT-TMJ
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-group clinical study will evaluate whether local peloid therapy improves pain and jaw function in adults with temporomandibular joint dysfunction. Participants will receive peloid therapy applied to the temporomandibular joint region and masticatory muscles for 20 minutes per session, 5 days per week, for 2 weeks. Pain and functional outcomes will be measured at baseline and at the end of treatment using validated clinical scales, including the Jaw Functional Limitation Scale-8, visual analog scale pain scores, Fonseca index, maximum mouth opening, and secondary otalgia assessment.

Conditions

Temporomandibular Disorders (TMDs); Pain; Otalgia

Keywords

TMJ Disorders; pain; otalgia

Outcome Measures

Primary Outcomes (1)

• Change in Jaw Function Score at Week 2

  Jaw function will be assessed using the Jaw Functional Limitation Scale-8 (JFLS-8). This is a patient-reported questionnaire that measures limitation in jaw activities such as chewing, speaking, and mouth opening. The total score ranges from 0 to 10, where 0 indicates no functional limitation and 10 indicates the highest level of limitation. The primary outcome will be the change in JFLS-8 total score from baseline to Week 2.

  Baseline and Week 2

Study Arms (1)

Peloid Therapy

EXPERIMENTAL

Other: Local Peloid Therapy

Interventions

Local Peloid Therapy OTHER

Participants will receive local peloid therapy applied externally over the temporomandibular joint region and adjacent masticatory muscles. The treatment will be delivered as 10 sessions over 2 weeks, with 5 sessions per week. Each session will last 20 minutes. Peloid therapy will be administered by a trained investigator according to the study protocol.

Peloid Therapy

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years Diagnosis of temporomandibular joint dysfunction based on DC/TMD criteria Presence of TMJ-related pain for at least 4 weeks Baseline pain intensity ≥3 on a 0-10 visual analog scale Ability to provide written informed consent

You may not qualify if:

• History of temporomandibular joint trauma, tumor, active infection, or acute inflammation Previous temporomandibular joint surgery Presence of systemic inflammatory rheumatologic disease Pregnancy Open wound, active dermatitis, or skin condition preventing peloid application at the treatment site Injection therapy (e.g., botulinum toxin) or regular physical therapy for TMJ within the past 3 months Any clinical or behavioral condition that may interfere with study compliance

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Uşak University Faculty of Medicine

Uşak, Merkez, 64420, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Sun R, Liu T, Liu Y, Zhang S, Yue Y, Jiang N, Zhang L, Xiong X. Simplified Jaw Functional Limitation Scale for Temporomandibular Disorders: Psychometric Evaluation. Oral Dis. 2025 Jun;31(6):1854-1860. doi: 10.1111/odi.15253. Epub 2025 Jan 10.

  PMID: 39791447 BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

• Ramazani F, Szalay-Anderson C, Batista AV, Park P, Hwang E, Chau J, Lui J. Referred otalgia: Common causes and evidence-based strategies for assessment and management. Can Fam Physician. 2023 Nov;69(11):757-761. doi: 10.46747/cfp.6911757.

  PMID: 37963787 BACKGROUND

• Kuttila SJ, Kuttila MH, Niemi PM, Le Bell YB, Alanen PJ, Suonpaa JT. Secondary otalgia in an adult population. Arch Otolaryngol Head Neck Surg. 2001 Apr;127(4):401-5. doi: 10.1001/archotol.127.4.401.

  PMID: 11296048 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain; Earache

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ear Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Faruk Kadri Bakkal, MD, Asistant Professor

CONTACT

+90 276 224 00 00; fkbakkal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)