An Follow-up Study of Occlusal Adjustment for Orofacial Pain

Not Applicable

Recruiting

• Conditions: Orofacial Pain; Trigeminal Neuralgia
• Interventions: Other: occlusal adjustment

• Registration Number: NCT02856906
• Lead Sponsor: Meiqing Wang

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.

Study Timeline

• Study First Submitted: 2016-07-15
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Occlusal adjustment group	occlusal adjustment	Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results.

Primary Outcome Measures

Name	Time	Method
Pain reduction assessed on the Visual Analog Scale（VAS）	4-weeks after the treatment

Secondary Outcome Measures

Name	Time	Method
The dosage of medicine	1-, 4-, 12-, 24-weeks after the treatment.	Grams per day of patients take the medicine .
Pain reduction assessed on the short form-McGill-2	1-,4-,12-,24-weeks after the treatment	Pain' levels reduction assessed on score of short form-McGill-2 .
Pain reduction assessed on the Visual Analog Scale（VAS）	1-, 12-, 24-weeks after the treatment
Attack frequency	1-,4-,12-,24-weeks after the treatment	Times of attack per day stand for attack frequency

Trial Locations

Locations (1)

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, China