Anterior Deprogrammers for Reducing Pain and Masticatory Muscles Tension

Lukasz Adamczyk

Status: Unknown

Conditions: Temporomandibular Disorders

Treatments: Device: Deprogrammer Kois; Device: Deprogramer Sliding Guide; Device: Deprogrammer Dawson B-Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT03180671

Anterior Deprogrammers

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Group 1 Control

No Intervention group

Description:

Counselling with explanation of preventive procedures.

Group 2 deprogramer Sliding Guide

Active Comparator group

Description:

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

Treatment:

Device: Deprogramer Sliding Guide

Group 3 deprogrammer Dawson B-Splint

Active Comparator group

Description:

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

Treatment:

Device: Deprogrammer Dawson B-Splint

Group 4 deprogrammer Kois

Active Comparator group

Description:

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

Treatment:

Device: Deprogrammer Kois