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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ping On Ointment | Experimental | Ping On Ointment |
|
| Vaseline | Placebo Comparator | Vaseline with minor trace of Ping On ointment to give medicinal smell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ping On Ointment | Drug | Ping On Ointment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy in the Treatment of TMJ and Muscle Pain | 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). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Mandibular Function. | The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricky W. K. Wong, PhD | Orthodontics, Faculty of Dentistry, University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, The University of Hong Kong | Hong Kong | Hong Kong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20001836 | Derived | Li LC, Wong RW, Rabie AB. Clinical effect of a topical herbal ointment on pain in temporomandibular disorders: a randomized placebo-controlled trial. J Altern Complement Med. 2009 Dec;15(12):1311-7. doi: 10.1089/acm.2009.0129. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ping On Ointment Group | Ping On Ointment was used |
| FG001 | Placebo Group | Vaseline with minor trace of Ping On Ointment was used |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ping On Ointment Group | Ping On Ointment was used |
| BG001 | Placebo Group | Vaseline with minor trace of Ping On Ointment was used |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Efficacy in the Treatment of TMJ and Muscle Pain | 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). | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ping On Ointment Group | Ping On Ointment was used |
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In this study, the subjects were screened by clinical examinations and self-reported questionnaires. Ideally, the diagnosis should be made with a combination of radiographs, Magnetic Resonance Imaging or Computer Tomography.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ricky Wing Kit Wong, Associate professor in orthodontics | University of Hong Kong | 852-2859 0554 | fyoung@hkucc.hku.hk |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Vaseline | Drug | Placebo |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | The Mandibular Function. | The mandibular function, the maximal comfortable mandibular opening measured in millimeters at the subjects's maximum incisor to incisor mouth opening using a ruler. | Posted | Mean | Standard Deviation | mm | 4 weeks |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Placebo Group | Vaseline with minor trace of Ping On Ointment was used | 0 | 22 | 0 | 22 |
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |