Systemic vs. topical Reparil 'Registered Trademark' for the treatment of Temporomandibular Joint and Masticatory Muscle Pain
The effectiveness of using systemic oral tablet Reparil 'Registered Trademark' vs. topical gel of Reparil 'Registered Trademark' compared to placebo in the treatment of temporomandibular joint (TMJ), masticatory muscle pain, mandibular function and Tolerability to treatment.
Hawler Medical University
50 participants
Dec 1, 2014
Interventional
Conditions
Summary
To compare the effectiveness of using systemic oral tablet Reparil 'Registered Trademark' vs. topical gel of Reparil 'Registered Trademark' compared to placebo in the treatment of temporomandibular joint (TMJ), masticatory muscle pain, mandibular function and Tolerability to treatment.
Eligibility
Inclusion Criteria3
- Self report of facial ache or pain in the muscles of mastication, the TMJ, or the region in front of ear or inside the ear
- Positive clinical diagnosis of TMDs. The TMD diagnosis is classified using axis I of the research diagnostic criteria (RDC) for TMDs. The RDC diagnosis consists of joint pain at rest (spontaneous pain) and evoked pain (hyperalgesia) on palpation of the TMJ, TMJ reduction consists of reciprocal clicking or joint noise with mandibular movement examination.
- For joint pain complaint, subjects will be required to have a self-report of at least 1 month of daily or nearly daily pain.
Exclusion Criteria7
- Subjects with infectious arthritis, crystal induced arthropathies, musculoskeletal disorders, subjects with a primary diagnosis of myofascial pain based on the RDC;
- Subjects with pain attributable to confirmed migraine or head pain condition other than tension headache;
- Subjects with acute infection or other significant disease of teeth, ears, eyes, nose or throats; subjects with untreated depressive disorder or not on stable antidepressant medication for more than 6 months;
- Subjects with dental diseases that required ongoing treatment, which would confound the evaluation of orofacial pain;
- Subjects who are not competent in giving consents.
- Pregnant or lactating women
- Subjects with sensitivity to the ingredient of Reparil
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Interventions
Reparil dragees COMPOSITION: Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:2 dragees (oral administration) Duration 3 times daily Mode of administration: oral drag Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months Reparil-gel N COMPOSITION: 100 g contains Aescin 1,0 g Diethylamine salicylate 5,0 g Dose:Spread a thin layer of the gel onto the skin of the affected area Duration 3 times daily Mode of administration:Topical Method of monitor adherence: follow up the patients weekly for the progress of treatment with the compliance to treatment, by telephone or messenger or visit. Duration of treatment: 1 month Follow up duration: 3 months
Locations(1)
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ACTRN12615000310561