Clinical trial NCT02992379: Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint
Official title: Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint as Treatment for TMJ Anterior Disc Displacement Without Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMJ Disc Disorder
Keywords: Anterior disc displacement
Stabilizing splint
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patients' subjective pain experience (numerical rating scale)
timeFrame: 6 months
Secondary outcomes:
measure: Maximum mouth opening (Unit: mm)
timeFrame: 6 months
measure: Lateral excursion (Unit: mm)
timeFrame: 6 months
measure: Protrusion (distance in mm)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nadia Galal, Ass.prof
role: STUDY_DIRECTOR
References:
citation: Ebrahim S, Montoya L, Busse JW, Carrasco-Labra A, Guyatt GH; Medically Unexplained Syndromes Research Group. The effectiveness of splint therapy in patients with temporomandibular disorders: a systematic review and meta-analysis. J Am Dent Assoc. 2012 Aug;143(8):847-57. doi: 10.14219/jada.archive.2012.0289.