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NCT Number: NCT07598994

Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain

The goal of this clinical trial is to compare the effectiveness and safety of topical capsaicin cream and topical diclofenac gel in women with chronic temporomandibular joint-related pain. The main questions it aims to answer are:

* Does topical capsaicin reduce pain intensity more effectively than topical diclofenac? * Do the treatments improve jaw function, pressure pain threshold, and neuropathic pain symptoms?

Researchers will compare topical capsaicin cream with topical diclofenac gel to evaluate differences in pain relief and functional improvement.

Participants will:

* Apply the assigned topical medication four times daily for 7 days * Attend clinical examinations and pain assessments at baseline, Day 8, and Month 1 * Complete pain-related questionnaires and functional jaw measurements during follow-up visits

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Dentistry

Istanbul, 34093, Turkey (Türkiye)

About this study

This randomized prospective single-blind clinical trial was designed to evaluate the efficacy and safety of topical capsaicin cream compared with topical diclofenac diethylammonium gel in female patients with chronic temporomandibular joint-related pain. Fifty women aged between 18 and 65 years diagnosed with temporomandibular disorders were randomly assigned to either the capsaicin group or the diclofenac group.

Participants in the capsaicin group applied 0.075% topical capsaicin cream, while participants in the diclofenac group applied 1% diclofenac diethylammonium gel. Both medications were applied four times daily over the temporomandibular joint lateral pole region for 7 days. Existing occlusal splint therapy was continued throughout the study period.

Clinical evaluations were performed at baseline, Day 8, and Month 1. Outcome measures included pain intensity assessed with a visual analog scale, multidimensional pain assessment using the McGill Pain Questionnaire, neuropathic pain evaluation using the DN4 questionnaire, pressure pain threshold measurements, maximum mouth opening, lateral mandibular movements, clinician global impression of change, and adverse effects.

The study was approved by the Istanbul University Faculty of Dentistry Clinical Research Ethics Committee and conducted in accordance with the Declaration of Helsinki.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female participants aged between 18 and 65 years
  • Diagnosis of temporomandibular disorder (TMD)-related pain
  • Presence of pain for at least 3 months
  • Baseline pain intensity sufficient to require treatment
  • Willingness to comply with study procedures and follow-up visits
  • Signed informed consent form

Exclusion criteria

  • Pregnancy or breastfeeding
  • History of allergy or hypersensitivity to capsaicin or diclofenac
  • Presence of systemic inflammatory or neurological disease
  • Use of systemic analgesics, corticosteroids, or muscle relaxants during the study period
  • Active skin lesions or dermatologic disease in the application area
  • Previous temporomandibular joint surgery
  • Participation in another clinical trial within the last 30 days
  • Inability to comply with study procedures

Treatment and study plan

Capsaicin Topical Cream

Drug

Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.

Other names: Capsaicin 0.075% Cream

Diclofenac 1% topical

Drug

Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.

Other names: Diclofenac Diethylammonium 1% Gel

Primary outcomes

  1. Change in pain intensity measured by Visual Analog Scale (VAS)

    Time frame: Baseline, Day 8, and 1 Month

    Pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS) in patients with temporomandibular disorder-related pain. Changes in VAS scores were compared between the capsaicin and diclofenac

Secondary outcomes

  1. Pressure Pain Threshold

    Time frame: Baseline, Day 8, and 1 Month

    Pressure pain threshold over the temporomandibular joint lateral pole measured using a dolorimeter.

  2. Maximum Mouth Opening

    Time frame: Baseline, Day 8, and 1 Month

    Maximum interincisal mouth opening measured in millimeters.

  3. McGill Pain Questionnaire Scores

    Time frame: Baseline, Day 8, and 1 Month

    Pain severity assessed using the McGill Pain Questionnaire.

  4. DN4 Neuropathic Pain Scores

    Time frame: Baseline, Day 8, and 1 Month

    Neuropathic pain symptoms assessed using the DN4 questionnaire.

  5. Lateral Excursion Measurements

    Time frame: Baseline, Day 8, and 1 Month

    Right and left mandibular lateral excursion movements measured in millimeters.

  6. Clinician Global Impression of Change (CGIC)

    Time frame: Day 8, and 1 Month

    Clinical improvement assessed using the Clinician Global Impression of Change scale.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain: A Randomized, Prospective, Single-Blind Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
Jul 1, 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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