Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

NCT03180671 | Unknown DMC FDA Device

• 1 other identifier: Anterior Deprogrammers
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Keywords

anterior deprogrammer; muscle pain; centric relation

Outcome Measures

Primary Outcomes (1)

• Electromyography

  Examination of masseters and temporal muscles tension

  2 min

Secondary Outcomes (1)

• Centric relation

  5 min

Study Arms (4)

Group 1 Control

NO INTERVENTION

Counselling with explanation of preventive procedures.

Group 2 deprogramer Sliding Guide

ACTIVE COMPARATOR

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

Device: Deprogramer Sliding Guide

Group 3 deprogrammer Dawson B-Splint

ACTIVE COMPARATOR

Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.

Device: Deprogrammer Dawson B-Splint

Group 4 deprogrammer Kois

ACTIVE COMPARATOR

Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.

Device: Deprogrammer Kois

Interventions

Deprogramer Sliding Guide DEVICE

Use of the intraoral device.

Also known as: Occlusal splint

Group 2 deprogramer Sliding Guide

Deprogrammer Dawson B-Splint DEVICE

Use of the intraoral device.

Also known as: Occlusal splint

Group 3 deprogrammer Dawson B-Splint

Deprogrammer Kois DEVICE

Use of the intraoral device.

Also known as: Occlusal splint

Group 4 deprogrammer Kois

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Lukasz Adamczyk: lead

Study Sites (1)

Dental Practice

Tarnów, 33-100, Poland

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Mieszko Wieckiewicz, DMD, MSc, PhD

  Wroclaw Medical University

  STUDY CHAIR

• Lukasz Adamczyk, DMD

  Dental Practice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mieszko Wieckiewicz, DMD, MSc, PhD

CONTACT

48660478759; m.wieckiewicz@onet.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 8, 2017
• Study Start: April 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: May 1, 2019
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)