Evaluation Lingual Ring Splint

Study Overview
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Brief Summary
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To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction

Detailed Description
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To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc Displacement With Reduction. PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain relief and improvement of mouth opening , lateral excursion and protrusion Outcome: 1ry outcome: Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had. 2ry outcome: Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws protrusion. The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.

Official Title
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Clinical Evaluation of Lingual Ring Splint For Management Anterior Disc Displacement With Reduction (Pilot Study Clinical Trial)

Conditions
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TMJ Disc Disorder

Intervention / Treatment
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* Device: Lingual Ring Splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient from 15 to 50 years old. Report of pain in preauricular region, in the last 30 days, worsened by functional activities, such as chewing and talking. Presence of disc displacement with reduction, arthralgia and joint clicking that occurred at both middle to late opening and late closing (near maximum cuspation) and pain in the TMJ area aggravated by jaw movement and function. positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI). Exclusion Criteria: Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ. History of TMJ surgery. Individuals with dental pain. Individuals with myofascial pain, disc displacement with reduction or osteoarthritis. Individuals under dental or TMD management. Individuals wearing full or partial dentures. Individuals with major psychological disorders. Nonreducing dislocations of the articular disk in the acute form of TMD Consequences of condoyle fractures and/or fracture of another maxillofacial zone. In therapy for the same pathologies. Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis). Well-known pathologies of neurologic and/or psychic nature and other forms of migraine.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lingual Ring Splint<br>A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed. The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior arch will make the Ring around the tongue | Device: Lingual Ring Splint<br>* A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed. The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior archwill make the Ring around the tongue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' subjective pain experience. | Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum mouth opening. | measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm | 3 months | 
| Lateral excursion. | measuring the distance between midline of upper and lower jaws . Unit: mm | 3 months | 
| Protrusion. | The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior disc displacement, TMD therapy, internal derangement, Lingual Ring