Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

Not Applicable

• Conditions: Temporomandibular Disorders
• Interventions: Device: Deprogramer Sliding Guide; Device: Deprogrammer Kois; Device: Deprogrammer Dawson B-Splint

• Registration Number: NCT03180671
• Lead Sponsor: Lukasz Adamczyk

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-06
• Last Update Submitted: 2017-06-06
• Study First Posted: 2017-06-08
• Last Update Posted: 2017-06-08
• Primary Completion: 2019-01-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2 deprogramer Sliding Guide	Deprogramer Sliding Guide	Intervention using the Deprogrammer Sliding Guide for 12-15 minutes.
Group 4 deprogrammer Kois	Deprogrammer Kois	Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures.
Group 3 deprogrammer Dawson B-Splint	Deprogrammer Dawson B-Splint	Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures.

Primary Outcome Measures

Name	Time	Method
Electromyography	2 min	Examination of masseters and temporal muscles tension

Secondary Outcome Measures

Name	Time	Method
Centric relation	5 min	Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration)

Trial Locations

Locations (1)

Dental Practice; 🇵🇱 Tarnow, Poland