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Completed

NCT Number: NCT00812604

Analgesic Ointment on Temporomandibular Joint and Masticatory Muscle Pain

The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, The University of Hong Kong

Hong Kong, China

About this study

Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.

Who can participate

Healthy volunteers accepted: No

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

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 Ping On Ointment will be excluded.

Treatment and study plan

Ping On Ointment

Drug

Ping On Ointment

Other names: TCM topical analgesic

Vaseline

Drug

Placebo

Primary outcomes

  1. The Efficacy in the Treatment of TMJ and Muscle Pain

    Time frame: 4 weeks

    The efficacy in the treatment of TMJ and muscle pain is measured by a visual analogue scale (VAS).

    The VAS consists of a 100 mm line, anchored with the extremes of pain intensity represented as "no pain" ( 0 mm) and " worst pain possible" ( 100 mm).

Secondary outcomes

  1. The Mandibular Function.

    Time frame: 4 weeks

    The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Effect of an Analgesic Ointment on the Relief of Temporomandibular Joint and Masticatory Muscle Pain: a Randomized, Double Blinded, Placebo-controlled Study.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2008
Registry last updated
Jun 23, 2014

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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