Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

NCT ID: NCT03180671

Last Updated: 2017-06-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1 Control

Counselling with explanation of preventive procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 deprogramer Sliding Guide

Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.

Group Type ACTIVE_COMPARATOR

Deprogramer Sliding Guide

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Deprogrammer Dawson B-Splint

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Deprogrammer Kois

Intervention Type DEVICE

Use of the intraoral device.

Interventions

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Deprogramer Sliding Guide

Use of the intraoral device.

Intervention Type DEVICE

Deprogrammer Dawson B-Splint

Use of the intraoral device.

Intervention Type DEVICE

Deprogrammer Kois

Use of the intraoral device.

Intervention Type DEVICE

Other Intervention Names

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Occlusal splint Occlusal splint Occlusal splint

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lukasz Adamczyk

OTHER

Sponsor Role lead

Responsible Party

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Lukasz Adamczyk

Principal investigator

Responsibility Role SPONSOR_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

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Mieszko Wieckiewicz, DMD, MSc, PhD

Role: CONTACT

48660478759

Facility Contacts

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Lukasz Adamczyk, DMD

Role: primary

48511230863

Other Identifiers

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Anterior Deprogrammers

Identifier Type: -

Identifier Source: org_study_id

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