Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension (Deprogrammer)
Primary Purpose
Temporomandibular Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Deprogramer Sliding Guide
Deprogrammer Dawson B-Splint
Deprogrammer Kois
Sponsored by
About this trial
This is an interventional prevention trial for Temporomandibular Disorders focused on measuring anterior deprogrammer, muscle pain, centric relation
Eligibility Criteria
Inclusion Criteria:
- age 20-30 years old
- 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
Sites / Locations
- Dental PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group 1 Control
Group 2 deprogramer Sliding Guide
Group 3 deprogrammer Dawson B-Splint
Group 4 deprogrammer Kois
Arm Description
Counselling with explanation of preventive procedures.
Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.
Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.
Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.
Outcomes
Primary Outcome Measures
Electromyography
Examination of masseters and temporal muscles tension
Secondary Outcome Measures
Centric relation
Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03180671
Brief Title
Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension
Acronym
Deprogrammer
Official Title
The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lukasz Adamczyk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will be conducted in four groups of 20 patients in age of 20-30 years with complete dentition or single tooth loss in lateral regions, with masticatory muscle pain in the history or during examination and overuse and/or chronic tensing of the masticatory muscles. Patients will be randomly assigned to the groups.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
anterior deprogrammer, muscle pain, centric relation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Control
Arm Type
No Intervention
Arm Description
Counselling with explanation of preventive procedures.
Arm Title
Group 2 deprogramer Sliding Guide
Arm Type
Active Comparator
Arm Description
Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.
Arm Title
Group 3 deprogrammer Dawson B-Splint
Arm Type
Active Comparator
Arm Description
Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.
Arm Title
Group 4 deprogrammer Kois
Arm Type
Active Comparator
Arm Description
Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.
Intervention Type
Device
Intervention Name(s)
Deprogramer Sliding Guide
Other Intervention Name(s)
Occlusal splint
Intervention Description
Use of the intraoral device.
Intervention Type
Device
Intervention Name(s)
Deprogrammer Dawson B-Splint
Other Intervention Name(s)
Occlusal splint
Intervention Description
Use of the intraoral device.
Intervention Type
Device
Intervention Name(s)
Deprogrammer Kois
Other Intervention Name(s)
Occlusal splint
Intervention Description
Use of the intraoral device.
Primary Outcome Measure Information:
Title
Electromyography
Description
Examination of masseters and temporal muscles tension
Time Frame
2 min
Secondary Outcome Measure Information:
Title
Centric relation
Description
Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)
Time Frame
5 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 20-30 years old
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mieszko Wieckiewicz, DMD, MSc, PhD
Phone
48660478759
Email
m.wieckiewicz@onet.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mieszko Wieckiewicz, DMD, MSc, PhD
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lukasz Adamczyk, DMD
Organizational Affiliation
Dental Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Practice
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Adamczyk, DMD
Phone
48511230863
Email
lukasz-stom@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension
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