Systemic vs. topical Reparil 'Registered Trademark' for the treatment of Temporomandibular Joint and Masticatory Muscle Pain

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000310561
• Date of registration: 02/04/2015
• Prospective Registration: No
• Primary sponsor: Hawler Medical University
• Public title: Systemic vs. topical Reparil 'Registered Trademark' for the treatment of Temporomandibular Joint and Masticatory Muscle Pain
• Scientific title: 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.
• Date of first enrolment: 01/12/2014
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000310561.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 1 / Phase 2

Countries of recruitment

Iraq

Contacts

• Name: Prof Dr Tagreed Altaei

• Name: Prof Dr Tagreed Altaei

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Subjects with myogenic pain will be included if they meet inclusion and exclusion criteria since patients with TMDs are known to exhibit muscle pain secondary to their joint dysfunction.

Exclusion criteria: 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


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Musculoskeletal - Other muscular and skeletal disorders

Temporomandibular joint (TMJ) disorder ;masticatory muscle pain, ;mandibular function;
Temporomandibular joint (TMJ) disorder


masticatory muscle pain,
mandibular function

Intervention(s)

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

Primary Outcome(s)

Subjects were evaluated with standard measures of efficacy: compliance to therapy and patients’ as well as physicians’ global assessment for efficacy.
Global assessment of efficacy was performed using the following grades: (i) excellent = reduction of >75% of symptoms, (ii) good = reduction of 51–75% of symptoms, (iii) fair = reduction of 26–50% of symptoms, and (iv) poor = no improvement or reduction in <25% of symptoms. [1 month for treatment
3 months for followup after completion of treatment]

Tolerability was assessed by recording patients’ global assessment; the tolerability of the drug and percent of the patients experiencing any drug-related adverse events (like sensitivity to the components).
The global assessment of tolerability was performed using following grades: (i) excellent = no adverse drug reaction, (ii) good = mild adverse drug reaction but no interference with normal lifestyle, (iii) fair = mild adverse drug reaction which interference with normal lifestyle. However, benefits of drug therapy outweigh the inconvenience, (iv) poor = drug withdrawn.
[1 month for treatment
3 months for followup after completion of treatment]

Pain intensity measured by Brief Pain Inventory, and McGill pain, and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.
[At baseline and again after 4 weeks of treatment.]

Secondary Outcome(s)

The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler, as a secondary outcome.
[1 month for treatment
3 months for followup post completion of treatment ]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Dr Tagreed Altaei