Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .

Not Applicable

• Conditions: TMJ Disc Disorder

• Registration Number: NCT02960048
• Lead Sponsor: Cairo University

Brief Summary

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

Detailed Description

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

PICO:

Population (P): Patients with symptomatic anterior disc displacement with reduction.

Intervention (I): Michigan splint. Comparator (C): Anterior repositioning splint (ARS) .

Outcome(O):

Primary 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.

Secondary outcome:

1. 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.

2. lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws

3. protrusion. 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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-08
• Last Update Submitted: 2016-11-08
• Study First Posted: 2016-11-09
• Last Update Posted: 2016-11-09
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult patient from 15 to 50 years old.
2. Report of pain in preauricular region worsened by functional activities, such as chewing and talking.
3. Presence of disc displacement with reduction and joint clicking
4. positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

Exclusion Criteria

1. . .
2. History of TMJ surgery.
3. Individuals with osteoarthritis.
4. Individuals under TMD management.
5. Individuals wearing full or partial dentures.
6. Individuals with major psychological disorders.
7. Nonreducing dislocations of the articular disc
8. Consequences of condyle fractures and/or fracture of another maxillofacial zone.
9. Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).
10. Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patients' subjective pain experience.	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Maximum mouth opening.	3 months	measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm
Lateral excursion.	3 months	measuring the distance between midline of upper and lower jaws . Unit: mm
Protrusion.	3 months	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.