- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02856906
An Follow-up Study of Occlusal Adjustment for Orofacial Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
T-scan analysis system is used to record the occlusal contact relationships. And at same time, Electromyographic recording system is used to record the Masseter (MM) and Anterior Temporalis (TA) muscles' surface electromyographic (SEMG) in the two time points: before the treatment and 4-weeks follow-up after treatment.
After recording, several parameters is taken to indicate the occlusal changes when researchers set the T-Scan occlusal parameters as 100% intercuspal position (ICP) maximum voluntary clenching (MVC), 75% ICP-MVC, 50% ICP-MVC, 25% ICP-MVC, and the number of occlusal contact and the values of the the Masseter (MM) and Anterior Temporalis (TA) muscles' surface electromyographic (SEMG) values is acquired by the software in the screen.
Occlusal imprints which indicates the their occlusal relationships is made by researchers when the volunteers ICP clenching in the two time points: before the treatment and 4-weeks follow-up after treatment.
Break-over and the sub-break-over point of the occlusal imprints is amplified by software. The investigators compute the number and area about that.
- The investigators also recorded frequency of attack and score of visual analogue scale (VAS), the dosage of drug, and short form-McGill-2 in the follow-ups time frame: immediately after the first treatment, 1-, 4-, 12- and 24-weeks after treatment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shaoxiong Guo, M.D
- Phone Number: 8615902969892
- Email: xiongshao1989@163.com
Study Locations
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Shaanxi
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Xi'an, Shaanxi, China, 710032
- Recruiting
- State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology and TMD,School of Stomatology, The Fourth Military Medical University, Xi 'an, China.
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Contact:
- Shaoxiong Guo, M.D
- Phone Number: 8615902969892
- Email: xiongshao1989@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patients claim orofacial pain. The pain has been treated but not relieved by medication, surgery, root canal therapy, even teeth extracting, or the pain relieve effect went down for a period. The patients also match the following item 1 or 2:
- Item 1: disorder characterized by recurrent unilateral brief electric shock-like pains, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve and triggered by innocuous stimuli. It may develop without apparent cause or be a result of another diagnosed disorder. There may or may not be, additionally, persistent background facial pain of moderate intensity.They fulfilled criteria A-E
- At least three attacks of unilateral facial pain fulfilling criteria B and C
- Occurring in one or more divisions of the trigeminal nerve, with no radiation beyond the trigeminal distribution
Pain has at least three of the following four characteristics:
- recurring in paroxysmal attacks lasting from a fraction of a second to 2 minutes.
- severe intensity.
- electric shock-like, shooting, stabbing or sharp in quality.
- precipitated by innocuous stimuli to the affected side of the face.
- No clinically evident neurological deficit
- Not better accounted for by another the International Classification of Headache Disorders 3rd edition diagnosis.
- Item 2 Persistent facial and/or oral pain, with varying presentations but recurring daily for more than 2 hours per day over more than 3 months, in the absence of clinical neurological deficit.They fulfilled criteria A-E
- Facial and/or oral pain fulfilling criteria B and C
- Recurring daily for >2 hours per day for >3 months
- Pain has both of the following characteristics: 1. poorly localized, and not following the distribution of a peripheral nerve 2. Dull, aching or nagging quality
- Clinical neurological examination is normal
- A dental cause has been excluded by appropriate investigations
- Not better accounted for by another the International Classification of Headache Disorders 3rd edition diagnosis
Exclusion Criteria:
- Head and facial trauma; orofacial and/or intracranial space occupying lesion indicated by craniofacial CT ; pain caused by sinusitis and acute pulpitis, periapical periodontitis and periodontitis disease; no occlusal abnormalities and occlusion treatment indications through a series of occlusal examination; children (younger than 18 years old) and pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Occlusal adjustment group
Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain reduction assessed on the Visual Analog Scale(VAS)
Time Frame: 4-weeks after the treatment
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4-weeks after the treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain reduction assessed on the Visual Analog Scale(VAS)
Time Frame: 1-, 12-, 24-weeks after the treatment
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1-, 12-, 24-weeks after the treatment
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Attack frequency
Time Frame: 1-,4-,12-,24-weeks after the treatment
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Times of attack per day stand for attack frequency
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1-,4-,12-,24-weeks after the treatment
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Pain reduction assessed on the short form-McGill-2
Time Frame: 1-,4-,12-,24-weeks after the treatment
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Pain' levels reduction assessed on score of short form-McGill-2 .
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1-,4-,12-,24-weeks after the treatment
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The dosage of medicine
Time Frame: 1-, 4-, 12-, 24-weeks after the treatment.
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Grams per day of patients take the medicine .
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1-, 4-, 12-, 24-weeks after the treatment.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of break-over point of occlusal imprints.
Time Frame: 4-weeks after treatment
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4-weeks after treatment
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Number of sub-break-over point of occlusal imprints.
Time Frame: 4-weeks after treatment
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4-weeks after treatment
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Area of break-over point of occlusal imprints(cm2) .
Time Frame: 4-weeks after treatment
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Area of break-over point of occlusal imprints(cm2) is computed by software.
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4-weeks after treatment
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Area of sub-break-over point of occlusal imprints(cm2).
Time Frame: 4-weeks after treatment
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Area of sub-break-over point of occlusal imprints(cm2) is computed by software.
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4-weeks after treatment
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Occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).
Time Frame: 4-weeks after the treatment
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The T-scan analysis system indicates the value of left and right side occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).
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4-weeks after the treatment
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Number of occlusal contact in T-Scan system in ICP-MVC
Time Frame: 4-weeks after the treatment
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The T-scan analysis system indicates the number of left and right side occlusal contact in ICP-MVC.
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4-weeks after the treatment
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Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in ICP-MVC.
Time Frame: 4-weeks after the treatment
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The system indicates left and right side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG) (uV)in ICP-MVC.
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4-weeks after the treatment
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Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.
Time Frame: 4-weeks after the treatment
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The system indicates right and left side Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.
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4-weeks after the treatment
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Occlusal force ratio(%)of dental arch in lateral cuspal to cuspal.
Time Frame: 4-weeks after treatment
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T-scan analysis system indicates the value of working and non-working side dental arch occlusal force ratio(%) in lateral cuspal to cuspal.
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4-weeks after treatment
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Number of occlusal contact in lateral cuspal to cuspal
Time Frame: 4-weeks after treatment
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T-scan analysis system indicates number of occlusal contact of working and non-working side in lateral cuspal to cuspal.
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4-weeks after treatment
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Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in lateral cuspal to cuspal.
Time Frame: 4-weeks after treatment
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The system indicates working and non-working side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
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4-weeks after treatment
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Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Time Frame: 4-weeks after treatment
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The system indicates non-working and working side Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
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4-weeks after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shaoxiong Guo, M.D, State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology and TMD,School of Stomatology, The Fourth Military Medical University, Xi 'an, China.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Peripheral Nervous System Diseases
- Cranial Nerve Diseases
- Facial Nerve Diseases
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Neuralgia
- Facial Pain
- Trigeminal Neuralgia
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- Department of Oral Anatomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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