Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension
NCT ID: NCT03180671
Last Updated: 2017-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2017-04-01
2019-05-01
Brief Summary
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Each person will be measured twice before and after use of selected anterior deprogrammer. The following assessment tools will be applied:
* surface electromyography of masseter and temporal muscles,
* intraoral pin-supported registration to draw a gothic arch.
Measurements will be made before and after intervention to assess the effect of anterior deprogrammer application on the tone of the selected masticatory muscles and condyles position in mandibular fossa. The first group (control) will be counsel with an explanation of the pathomechanism of masticatory muscles pain and preventive principles. In the second group, the Sliding Guide will be used for a period of 12-15 minutes, in the third Dawson B-Splint for 7 days, and in the fourth Kois deprogrammer for 14 days. Devices in group 3 and 4 will be used by patients for 24 hours a day, with breaks for oral hygiene procedures and eating/drinking.
The aim of the study is to evaluate the effectiveness of selected anterior deprogrammers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Group 1 Control
Counselling with explanation of preventive procedures.
No interventions assigned to this group
Group 2 deprogramer Sliding Guide
Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.
Deprogramer Sliding Guide
Use of the intraoral device.
Group 3 deprogrammer Dawson B-Splint
Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.
Deprogrammer Dawson B-Splint
Use of the intraoral device.
Group 4 deprogrammer Kois
Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.
Deprogrammer Kois
Use of the intraoral device.
Interventions
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Deprogramer Sliding Guide
Use of the intraoral device.
Deprogrammer Dawson B-Splint
Use of the intraoral device.
Deprogrammer Kois
Use of the intraoral device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* complete dentition or single tooth loss in the lateral regions
* no severe systemic diseases
* masticatory muscle pain in the history or during examination
* increased masticatory muscles tension
20 Years
30 Years
ALL
No
Sponsors
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Lukasz Adamczyk
OTHER
Responsible Party
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Lukasz Adamczyk
Principal investigator
Principal Investigators
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Mieszko Wieckiewicz, DMD, MSc, PhD
Role: STUDY_CHAIR
Wroclaw Medical University
Lukasz Adamczyk, DMD
Role: PRINCIPAL_INVESTIGATOR
Dental Practice
Locations
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Dental Practice
Tarnów, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Anterior Deprogrammers
Identifier Type: -
Identifier Source: org_study_id
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