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Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

NCT03180671 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-06-08

No results posted yet for this study

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.

Conditions

  • Temporomandibular Disorders

Interventions

DEVICE

Deprogramer Sliding Guide

Use of the intraoral device.

DEVICE

Deprogrammer Dawson B-Splint

Use of the intraoral device.

DEVICE

Deprogrammer Kois

Use of the intraoral device.

Sponsors & Collaborators

  • Lukasz Adamczyk

    lead OTHER

Principal Investigators

  • Mieszko Wieckiewicz, DMD, MSc, PhD · Wroclaw Medical University

  • Lukasz Adamczyk, DMD · Dental Practice

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-01-01
Completion
2019-05-01
FDA Device
Yes

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180671 on ClinicalTrials.gov