An Follow-up Study of Occlusal Adjustment for Orofacial Pain

February 6, 2024 updated by: Meiqing Wang
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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • 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.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusal adjustment group
Patients in this group will receive treatment of occlusal adjustment based on the clinical and lab examination results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction assessed on the Visual Analog Scale(VAS)
Time Frame: 4-weeks after the treatment
4-weeks after the treatment

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimated)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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