An Follow-up Study of Occlusal Adjustment for Orofacial Pain

NCT02856906 | Recruiting

• 1 other identifier: Department of Oral Anatomy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Orofacial Pain; Trigeminal Neuralgia

Keywords

Orofacial Pain; Electromyography; dental occlusion

Outcome Measures

Primary Outcomes (1)

• Pain reduction assessed on the Visual Analog Scale（VAS）

  4-weeks after the treatment

Secondary Outcomes (4)

• 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

• Pain reduction assessed on the short form-McGill-2

  1-,4-,12-,24-weeks after the treatment

• The dosage of medicine

  1-, 4-, 12-, 24-weeks after the treatment.

Other Outcomes (12)

• Number of break-over point of occlusal imprints.

  4-weeks after treatment

• 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 treatment

Study Arms (1)

Occlusal adjustment group

EXPERIMENTAL

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

Other: occlusal adjustment

Interventions

occlusal adjustment OTHER

Occlusal adjustment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meiqing Wang: lead

Study Sites (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, 710032, China

RECRUITING

MeSH Terms

Conditions

Facial Pain; Trigeminal Neuralgia; Bites and Stings

Interventions

Occlusal Adjustment

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• 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 CHAIR

Central Study Contacts

Shaoxiong Guo, M.D

CONTACT

8615902969892; xiongshao1989@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, State Key Laboratory of Military Stomatology, Department of Oral Anatomy and Physiology, School of Stomatology

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)