Istanbul University Faculty of Dentistry
Istanbul, 34093, Turkey (Türkiye)
NCT Number: NCT07598994
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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Notify Me18 year–65 year
Female
Interventional
Not applicable
Istanbul, 34093, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.
Other names: Capsaicin 0.075% Cream
Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.
Other names: Diclofenac Diethylammonium 1% Gel
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
Time frame: Baseline, Day 8, and 1 Month
Pressure pain threshold over the temporomandibular joint lateral pole measured using a dolorimeter.
Time frame: Baseline, Day 8, and 1 Month
Maximum interincisal mouth opening measured in millimeters.
Time frame: Baseline, Day 8, and 1 Month
Pain severity assessed using the McGill Pain Questionnaire.
Time frame: Baseline, Day 8, and 1 Month
Neuropathic pain symptoms assessed using the DN4 questionnaire.
Time frame: Baseline, Day 8, and 1 Month
Right and left mandibular lateral excursion movements measured in millimeters.
Time frame: Day 8, and 1 Month
Clinical improvement assessed using the Clinician Global Impression of Change scale.
Istanbul University
Other
Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain: A Randomized, Prospective, Single-Blind Clinical Trial
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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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