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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Group 4 deprogrammer Kois | Active Comparator | Intervention using the Kois deprogrammer for 14 days with breaks for eating/drinking and oral hygiene procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deprogramer Sliding Guide | Device | Use of the intraoral device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Electromyography | Examination of masseters and temporal muscles tension | 2 min |
| Measure | Description | Time Frame |
|---|---|---|
| Centric relation | Registration of centric relation with Sm-Registration-set (intraoral pin-supported registration) | 5 min |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mieszko Wieckiewicz, DMD, MSc, PhD | Contact | 48660478759 | m.wieckiewicz@onet.pl |
| Name | Affiliation | Role |
|---|---|---|
| Mieszko Wieckiewicz, DMD, MSc, PhD | Wroclaw Medical University | Study Chair |
| Lukasz Adamczyk, DMD | Dental Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Practice | Recruiting | Tarnów | 33-100 | Poland |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Deprogrammer Dawson B-Splint | Device | Use of the intraoral device. |
|
|
| Deprogrammer Kois | Device | Use of the intraoral device. |
|
|
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |