An Follow-up Study of Occlusal Adjustment for Orofacial Pain
Primary Purpose
Orofacial Pain, Trigeminal Neuralgia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
occlusal adjustment
Sponsored by
About this trial
This is an interventional treatment trial for Orofacial Pain focused on measuring Orofacial Pain, Electromyography, dental occlusion
Eligibility Criteria
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.
Sites / Locations
- 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.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Occlusal adjustment group
Arm Description
Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results.
Outcomes
Primary Outcome Measures
Pain reduction assessed on the Visual Analog Scale(VAS)
Secondary Outcome Measures
Pain reduction assessed on the Visual Analog Scale(VAS)
Attack frequency
Times of attack per day stand for attack frequency
Pain reduction assessed on the short form-McGill-2
Pain' levels reduction assessed on score of short form-McGill-2 .
The dosage of medicine
Grams per day of patients take the medicine .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02856906
Brief Title
An Follow-up Study of Occlusal Adjustment for Orofacial Pain
Official Title
An Follow-up Study of Occlusal Adjustment for Orofacial Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meiqing Wang
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether what kind of occlusion are related the orofacial pain under investigation, and whether occlusal adjustment have an effect in relief of this kind of orofacial pain.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orofacial Pain, Trigeminal Neuralgia
Keywords
Orofacial Pain, Electromyography, dental occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Occlusal adjustment group
Arm Type
Experimental
Arm Description
Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results.
Intervention Type
Other
Intervention Name(s)
occlusal adjustment
Primary Outcome Measure Information:
Title
Pain reduction assessed on the Visual Analog Scale(VAS)
Time Frame
4-weeks after the treatment
Secondary Outcome Measure Information:
Title
Pain reduction assessed on the Visual Analog Scale(VAS)
Time Frame
1-, 12-, 24-weeks after the treatment
Title
Attack frequency
Description
Times of attack per day stand for attack frequency
Time Frame
1-,4-,12-,24-weeks after the treatment
Title
Pain reduction assessed on the short form-McGill-2
Description
Pain' levels reduction assessed on score of short form-McGill-2 .
Time Frame
1-,4-,12-,24-weeks after the treatment
Title
The dosage of medicine
Description
Grams per day of patients take the medicine .
Time Frame
1-, 4-, 12-, 24-weeks after the treatment.
Other Pre-specified Outcome Measures:
Title
Number of break-over point of occlusal imprints.
Time Frame
4-weeks after treatment
Title
Number of sub-break-over point of occlusal imprints.
Time Frame
4-weeks after treatment
Title
Area of break-over point of occlusal imprints(cm2) .
Description
Area of break-over point of occlusal imprints(cm2) is computed by software.
Time Frame
4-weeks after treatment
Title
Area of sub-break-over point of occlusal imprints(cm2).
Description
Area of sub-break-over point of occlusal imprints(cm2) is computed by software.
Time Frame
4-weeks after treatment
Title
Occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).
Description
The T-scan analysis system indicates the value of left and right side occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).
Time Frame
4-weeks after the treatment
Title
Number of occlusal contact in T-Scan system in ICP-MVC
Description
The T-scan analysis system indicates the number of left and right side occlusal contact in ICP-MVC.
Time Frame
4-weeks after the treatment
Title
Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in ICP-MVC.
Description
The system indicates left and right side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG) (uV)in ICP-MVC.
Time Frame
4-weeks after the treatment
Title
Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.
Description
The system indicates right and left side Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.
Time Frame
4-weeks after the treatment
Title
Occlusal force ratio(%)of dental arch in lateral cuspal to cuspal.
Description
T-scan analysis system indicates the value of working and non-working side dental arch occlusal force ratio(%) in lateral cuspal to cuspal.
Time Frame
4-weeks after treatment
Title
Number of occlusal contact in lateral cuspal to cuspal
Description
T-scan analysis system indicates number of occlusal contact of working and non-working side in lateral cuspal to cuspal.
Time Frame
4-weeks after treatment
Title
Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in lateral cuspal to cuspal.
Description
The system indicates working and non-working side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Time Frame
4-weeks after treatment
Title
Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Description
The system indicates non-working and working side Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Time Frame
4-weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaoxiong Guo, M.D
Phone
8615902969892
Email
xiongshao1989@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoxiong Guo, M.D
Organizational Affiliation
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.
Official's Role
Study Chair
Facility Information:
Facility Name
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.
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaoxiong Guo, M.D
Phone
8615902969892
Email
xiongshao1989@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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An Follow-up Study of Occlusal Adjustment for Orofacial Pain
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