Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Temporomandibular disorder (TMD) is a common condition with multifactorial etiology, including trauma, emotional stress, parafunctional habits, and occlusal discrepancies. TMD may be classified as myogenous, involving the masticatory and cervical muscles, or arthrogenous, affecting the temporomandibular joint structures. Management approaches range from noninvasive to invasive methods. The intraoral stabilization appliance (SA) is a widely used noninvasive treatment, while the ear stent (ES) has recently been introduced for managing myogenous TMD.
Aim: This randomized clinical trial aims to compare the effectiveness of SA and ES in the management of myogenous TMD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stabilization appliance | Experimental | Maxillary and mandibular impressions will be taken using irreversible hydrocolloid and poured immediately with Type IV dental stone to obtain study casts. A maxillary stabilization appliance will be fabricated according to Okeson et al. using 2-mm hard thermoplastic sheets. The appliance will have a flat occlusal surface with buccal extensions, and its fit and retention will be verified. Participants will wear the appliance for 3 months. Surface electromyography of the temporalis and masseter muscles will be recorded at baseline and after 3 months to assess changes in muscle activity |
|
| Ear stent | Active Comparator | Participants will undergo ENT evaluation to exclude ear pathology and remove cerumen. Ear impressions will be taken using soft addition silicone injected with a 3.5-mm syringe and sent to a hearing-aid laboratory for fabrication. The stent will be hollowed longitudinally to prevent hearing impairment. Patients will be instructed to wear the stent full-time, removing it only during meals, showering, or swimming |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stabilization Appliance | Other | Participants will receive a maxillary stabilization appliance fabricated from 2-mm hard thermoplastic material using diagnostic casts. The appliance fit will be verified, and patients will be instructed to wear it for 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle activity | surface electromyography will be used to assess the temporalis and masseter muscles. The electrodes detect the electrical potentials generated by muscle fibers when they contract. This electrical activity is amplified and recorded by an electromyograph machine | Baseline and 3 months |
| Change in mouth opening | Measure the distance (in mm) between the incisal edge of the maxillary and mandibular central incisors | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain | NRS will be measured from the patient mark from 0 to 10, where 0 representing no pain and 10 representing the worst pain. | Baseline and 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa F Mohamed, BDS | Contact | 01018135577 | alaa127fikrey@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Faculty of Dentistry | Recruiting | Alexandria | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ear Stent | Other | Participants will undergo ENT evaluation prior to ear impression taking. Custom ear stents will be fabricated from soft addition silicone and hollowed to prevent hearing impairment. |
|