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Clinical Trials/NCT02992379
NCT02992379
Unknown
Not Applicable

Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint as Treatment for TMJ Anterior Disc Displacement Without Reduction

Cairo University0 sites30 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
TMJ Disc Disorder
Sponsor
Cairo University
Enrollment
30
Primary Endpoint
Patients' subjective pain experience (numerical rating scale)
Last Updated
9 years ago

Overview

Brief Summary

To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction

Detailed Description

To evaluate the effectiveness of the stabilizing splint versus the pivot splint as jaw exercise together with stabilizing splints for treatment of TMJ anterior disc displacement without reduction PICO: Population (P): Patients with symptomatic anterior disc displacement without reduction. Intervention (I): pivot splint. Comparator (C): stabilizing 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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hesham Mohamed mohamed elsayed safa

Resident at National Cancer Institute

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Individuals with systemic diseases that can affect TMJ
  • History of TMJ surgery
  • Individuals with osteoarthritis
  • Individuals under TMD management
  • Individuals wearing full or partial dentures
  • Reducing dislocations of the articular disc
  • Consequences of condyle 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)
  • Individuals with a recent history of trauma in the face and/or neck area

Outcomes

Primary Outcomes

Patients' subjective pain experience (numerical rating scale)

Time Frame: 6 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 Outcomes

  • Protrusion (distance in mm)(6 months)
  • Maximum mouth opening (Unit: mm)(6 months)
  • Lateral excursion (Unit: mm)(6 months)

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