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Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension (Deprogrammer)

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ClinicalTrials.gov Identifier: NCT03180671
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Lukasz Adamczyk, Wroclaw Medical University

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.


Condition or disease Intervention/treatment Phase
Temporomandibular Disorders Device: Deprogramer Sliding Guide Device: Deprogrammer Dawson B-Splint Device: Deprogrammer Kois Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
No Intervention: Group 1 Control
Counselling with explanation of preventive procedures.
Active Comparator: Group 2 deprogramer Sliding Guide
Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.
Device: Deprogramer Sliding Guide
Use of the intraoral device.
Other Name: Occlusal splint

Active Comparator: Group 3 deprogrammer Dawson B-Splint
Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.
Device: Deprogrammer Dawson B-Splint
Use of the intraoral device.
Other Name: Occlusal splint

Active Comparator: Group 4 deprogrammer Kois
Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.
Device: Deprogrammer Kois
Use of the intraoral device.
Other Name: Occlusal splint




Primary Outcome Measures :
  1. Electromyography [ Time Frame: 2 min ]
    Examination of masseters and temporal muscles tension


Secondary Outcome Measures :
  1. Centric relation [ Time Frame: 5 min ]
    Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180671


Contacts
Contact: Mieszko Wieckiewicz, DMD, MSc, PhD 48660478759 m.wieckiewicz@onet.pl

Locations
Poland
Dental Practice Recruiting
Tarnow, Poland, 33-100
Contact: Lukasz Adamczyk, DMD    48511230863    lukasz-stom@outlook.com   
Sponsors and Collaborators
Lukasz Adamczyk
Investigators
Study Chair: Mieszko Wieckiewicz, DMD, MSc, PhD Wroclaw Medical University
Principal Investigator: Lukasz Adamczyk, DMD Dental Practice

Responsible Party: Lukasz Adamczyk, Principal investigator, Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT03180671     History of Changes
Other Study ID Numbers: Anterior Deprogrammers
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Lukasz Adamczyk, Wroclaw Medical University:
anterior deprogrammer
muscle pain
centric relation

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents