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Trial registered on ANZCTR


Registration number
ACTRN12615000310561
Ethics application status
Approved
Date submitted
21/12/2014
Date registered
2/04/2015
Date last updated
2/04/2015
Type of registration
Retrospectively registered

Titles & IDs
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.
Secondary ID [1] 285883 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular joint (TMJ) disorder

 293803 0
masticatory muscle pain, 294096 0
mandibular function 294097 0
Condition category
Condition code
Musculoskeletal 294108 294108 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 290865 0
Treatment: Drugs
Comparator / control treatment
Glucose as oral tablet
Gel without active constituents
Control group
Placebo

Outcomes
Primary outcome [1] 293902 0
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.
Timepoint [1] 293902 0
1 month for treatment
3 months for followup after completion of treatment
Primary outcome [2] 293903 0
Pain intensity measured by Brief Pain Inventory, and McGill pain, and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.
Timepoint [2] 293903 0
At baseline and again after 4 weeks of treatment.
Primary outcome [3] 293904 0
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.
Timepoint [3] 293904 0
1 month for treatment
3 months for followup after completion of treatment
Secondary outcome [1] 312122 0
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.
Timepoint [1] 312122 0
1 month for treatment
3 months for followup post completion of treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
By numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2014
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6564 0
Iraq
State/province [1] 6564 0

Funding & Sponsors
Funding source category [1] 290467 0
Self funded/Unfunded
Name [1] 290467 0
Dr Tagreed Altaei
Country [1] 290467 0
Iraq
Primary sponsor type
University
Name
Hawler Medical University
Address
College of Dentistry/Hawler Medical University
60 meter
Erbil
44001
Kurdistan/Iraq
Country
Iraq
Secondary sponsor category [1] 289169 0
None
Name [1] 289169 0
None
Address [1] 289169 0
None
Country [1] 289169 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53686 0
Dr Tagreed Altaei
Address 53686 0
College of Dentistry/Hawler Medical University
Erbil 60 meter
44001
Kurdistan
Country 53686 0
Iraq
Phone 53686 0
+964 750 4941834
Fax 53686 0
Email 53686 0
tagreedaltaei@yahoo.com
Contact person for public queries
Name 53687 0
Dr Tagreed Altaei
Address 53687 0
College of Dentistry/Hawler Medical University
Erbil 60 meter
44001
Kurdistan
Country 53687 0
Iraq
Phone 53687 0
+964 750 4941834
Fax 53687 0
Email 53687 0
tagreedaltaei@yahoo.com
Contact person for scientific queries
Name 53688 0
Dr Tagreed Altaei
Address 53688 0
College of Dentistry/Hawler Medical University
Erbil 60 meter
44001
Kurdistan
Country 53688 0
Iraq
Phone 53688 0
+964 750 4941834
Fax 53688 0
Email 53688 0
tagreedaltaei@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.