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NCT Number: NCT07576582

Peloid Therapy in Temporomandibular Joint Dysfunction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uşak University Faculty of Medicine

Uşak, Merkez, 64420, Turkey (Türkiye)

Location status: Recruiting

Location contact

Faruk Kadri Bakkal

CONTACT

[email protected]

+90 276 224 00 00 ext. 4238

About this study

Temporomandibular joint dysfunction is associated with pain, impaired chewing, restricted jaw function, and, in some patients, referred otalgia. Conservative treatment options are commonly used as first-line management, but the clinical evidence for some physical therapy modalities remains limited.

Peloid therapy is a local thermotherapeutic intervention used in balneotherapy and physical medicine. It may provide analgesic and muscle-relaxing effects through superficial heat and local tissue responses. However, prospective data evaluating its clinical effect in temporomandibular joint dysfunction are limited.

This study is designed to assess changes in jaw-related functional limitation and pain after a standardized 2-week course of local peloid therapy in adults diagnosed with temporomandibular joint dysfunction. Functional status, pain intensity, mouth opening, symptom severity, and secondary otalgia will be assessed before and after treatment using standardized clinical measures.

The study may provide additional evidence on the role of peloid therapy as a conservative supportive treatment option for temporomandibular joint dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Jaw Function Score at Week 2

    Time frame: Baseline and 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.

Study contacts

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

Faruk Kadri Bakkal, MD, Asistant Professor

CONTACT

[email protected]

+90 276 224 00 00 ext. 4238

Sponsors and collaborators

Lead sponsor

Uşak University

Other

Registry information

Official study title

The Effect of Peloid Therapy on Pain and Functional Outcomes in Patients With Temporomandibular Joint Dysfunction

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
Jul 2, 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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