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

June 6, 2017 updated by: Lukasz Adamczyk

The Effectiveness of Anterior Deprogrammers as a Tool for Reducing Pain and Masticatory Muscles Tension

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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 Locations

  • Poland
      • Tarnow, Poland, 33-100
        • Recruiting
        • Dental practice
        • 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

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Occlusal splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography
Time Frame: 2 min
Examination of masseters and temporal muscles tension
2 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centric relation
Time Frame: 5 min
Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)
5 min

Collaborators and Investigators

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

Sponsor

Lukasz Adamczyk

Investigators

  • Study Chair: Mieszko Wieckiewicz, DMD, MSc, PhD, Wroclaw Medical University
  • Principal Investigator: Lukasz Adamczyk, DMD, Dental practice

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 (Actual)

April 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

June 3, 2017

First Submitted That Met QC Criteria

June 6, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anterior Deprogrammers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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