Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

Study Overview
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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.

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

Conditions
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Temporomandibular Disorders

Intervention / Treatment
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* Device: Deprogramer Sliding Guide
* Device: Deprogrammer Dawson B-Splint
* Device: Deprogrammer Kois


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1 Control<br>Counselling with explanation of preventive procedures. | |
| Active Comparator: Group 2 deprogramer Sliding Guide<br>Intervention using the Deprogrammer Sliding Guide for 12-15 minutes. | Device: Deprogramer Sliding Guide<br>* Use of the intraoral device.<br>* Other names: Occlusal splint;|
| Active Comparator: Group 3 deprogrammer Dawson B-Splint<br>Intervention using the Dawson B-Splint for 7 days with breaks for eating/drinking and oral hygiene procedures. | Device: Deprogrammer Dawson B-Splint<br>* Use of the intraoral device.<br>* Other names: Occlusal splint;|
| Active Comparator: Group 4 deprogrammer Kois<br>Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures. | Device: Deprogrammer Kois<br>* Use of the intraoral device.<br>* Other names: Occlusal splint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyography | Examination of masseters and temporal muscles tension | 2 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Centric relation | Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration) | 5 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior deprogrammer, muscle pain, centric relation