Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

Temporomandibular Disorders Clinical Trial

— Deprogrammer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03180671
• Other study ID #: Anterior Deprogrammers
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2017
• Last updated: June 6, 2017
• Start date: April 1, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2017
• Source: Wroclaw Medical University
• Contact: Mieszko Wieckiewicz, DMD, MSc, PhD
• Phone: 48660478759
• Email: m.wieckiewicz[@]onet.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Deprogramer Sliding Guide
Use of the intraoral device.
• Deprogrammer Dawson B-Splint
Use of the intraoral device.
• Deprogrammer Kois
Use of the intraoral device.

Locations

Country	Name	City	State
Poland	Dental Practice	Tarnow

Sponsors (1)

Lead Sponsor	Collaborator
Lukasz Adamczyk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyography	Examination of masseters and temporal muscles tension	2 min
Secondary	Centric relation	Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)	5 min