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An Follow-up Study of Occlusal Adjustment for Orofacial Pain

An Follow-up Study of Occlusal Adjustment for Orofacial Pain

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02856906
Enrollment
30
Registered
2016-08-05
Start date
2016-08-31
Completion date
2025-12-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orofacial Pain, Trigeminal Neuralgia

Keywords

Orofacial Pain, Electromyography, dental occlusion

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

1. 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. 2. 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. 3. 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.

Interventions

Sponsors

Meiqing Wang
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pain reduction assessed on the Visual Analog Scale(VAS)4-weeks after the treatment

Secondary

MeasureTime frameDescription
Pain reduction assessed on the Visual Analog Scale(VAS)1-, 12-, 24-weeks after the treatment
Attack frequency1-,4-,12-,24-weeks after the treatmentTimes of attack per day stand for attack frequency
Pain reduction assessed on the short form-McGill-21-,4-,12-,24-weeks after the treatmentPain' levels reduction assessed on score of short form-McGill-2 .
The dosage of medicine1-, 4-, 12-, 24-weeks after the treatment.Grams per day of patients take the medicine .

Other

MeasureTime frameDescription
Number of occlusal contact in T-Scan system in ICP-MVC4-weeks after the treatmentThe T-scan analysis system indicates the number of left and right side occlusal contact in ICP-MVC.
Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in ICP-MVC.4-weeks after the treatmentThe system indicates left and right side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG) (uV)in ICP-MVC.
Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.4-weeks after the treatmentThe system indicates right and left side Masseter (MM) surface electromyographic(SEMG)(uV)in ICP-MVC.
Number of break-over point of occlusal imprints.4-weeks after treatment
Number of occlusal contact in lateral cuspal to cuspal4-weeks after treatmentT-scan analysis system indicates number of occlusal contact of working and non-working side in lateral cuspal to cuspal.
Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV) in lateral cuspal to cuspal.4-weeks after treatmentThe system indicates working and non-working side Anterior Temporalis (TA) muscles' surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.4-weeks after treatmentThe system indicates non-working and working side Masseter (MM) surface electromyographic(SEMG)(uV)in lateral cuspal to cuspal.
Occlusal force ratio(%)of dental arch in lateral cuspal to cuspal.4-weeks after treatmentT-scan analysis system indicates the value of working and non-working side dental arch occlusal force ratio(%) in lateral cuspal to cuspal.
Number of sub-break-over point of occlusal imprints.4-weeks after treatment
Area of break-over point of occlusal imprints(cm2) .4-weeks after treatmentArea of break-over point of occlusal imprints(cm2) is computed by software.
Area of sub-break-over point of occlusal imprints(cm2).4-weeks after treatmentArea of sub-break-over point of occlusal imprints(cm2) is computed by software.
Occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).4-weeks after the treatmentThe T-scan analysis system indicates the value of left and right side occlusal force ratio(%)in position (ICP)- maximum voluntary clenching (MVC).

Countries

China

Contacts

Primary ContactShaoxiong Guo, M.D
xiongshao1989@163.com8615902969892

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026