Orofacial PainNCT02856906
An Follow-up Study of Occlusal Adjustment for Orofacial Pain
A study testing occlusal adjustment in people with Orofacial Pain and Trigeminal Neuralgia, run by Meiqing Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orofacial Pain, Trigeminal Neuralgia
- What is being tested?
- occlusal adjustment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- 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.
Xi'an, Shaanxi, 710032
Shaoxiong Guo, M.D, 8615902969892, xiongshao1989@163.com
About this study
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.
Read the 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.
- Conditions
- Orofacial Pain, Trigeminal Neuralgia
- Being tested
- occlusal adjustment
- Keywords
- Orofacial Pain, Electromyography, dental occlusion
- Medical subject headings
- Facial Pain, Trigeminal Neuralgia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal adjustmentOther
| Study group | Role | What they receive |
|---|---|---|
| Occlusal adjustment group | Experimental | Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results. Receives: Other: occlusal adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction assessed on the Visual Analog Scale（VAS）
Measured: 4-weeks after the treatment
Secondary outcomes (4)
Pain reduction assessed on the Visual Analog Scale（VAS）
Measured: 1-, 12-, 24-weeks after the treatment
Attack frequency
Times of attack per day stand for attack frequency
Measured: 1-,4-,12-,24-weeks after the treatment
Pain reduction assessed on the short form-McGill-2
Pain' levels reduction assessed on score of short form-McGill-2 .
Measured: 1-,4-,12-,24-weeks after the treatment
The dosage of medicine
Grams per day of patients take the medicine .
Measured: 1-, 4-, 12-, 24-weeks after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meiqing Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meiqing Wang, Air Force Military Medical University, China
- Investigators
- Shaoxiong Guo, M.D, Study chair, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02856906
- Sponsor's protocol ID
- Department of Oral Anatomy
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2016
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Follow-up Study of Occlusal Adjustment for Orofacial Pain
- ClinicalTrials.gov ID
- NCT02856906
- Acronym / sponsor ID
- Department of Oral Anatomy
- Conditions
- Orofacial Pain, Trigeminal Neuralgia
- Keywords
- Orofacial Pain, Electromyography, dental occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meiqing WangUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occlusal adjustment group | Experimental | Other: occlusal adjustmentPatients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occlusal adjustment | Other | Occlusal adjustment group |
Primary outcome
Pain reduction assessed on the Visual Analog Scale（VAS）
Time frame: 4-weeks after the treatment
4 secondary outcomes
Pain reduction assessed on the Visual Analog Scale（VAS）
Time frame: 1-, 12-, 24-weeks after the treatment
Attack frequency
Time frame: 1-,4-,12-,24-weeks after the treatment
Pain reduction assessed on the short form-McGill-2
Time frame: 1-,4-,12-,24-weeks after the treatment
The dosage of medicine
Time frame: 1-, 4-, 12-, 24-weeks after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaoxiong Guo, M.D study chair
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal adjustment in people with Orofacial Pain and Trigeminal Neuralgia, run by Meiqing Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaoxiong Guo, M.D (8615902969892, xiongshao1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction assessed on the Visual Analog Scale（VAS） (time frame: 4-weeks after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.