Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint

Not Applicable

• Conditions: TMJ Disc Disorder
• Interventions: Device: pivot splint; Device: stabilizing splint

• Registration Number: NCT02992379
• Lead Sponsor: Cairo University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2016-11-29
• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-10
• Last Update Submitted: 2016-12-10
• Study First Posted: 2016-12-14
• Last Update Posted: 2016-12-14
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stabilizing splint	pivot splint	Active Comparator: stabilizing splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint
pivot splint	pivot splint	Experimental: pivot splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks. Other Names: PS
stabilizing splint	stabilizing splint	Active Comparator: stabilizing splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint
pivot splint	stabilizing splint	Experimental: pivot splint A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks. Other Names: PS

Primary Outcome Measures

Name	Time	Method
Patients' subjective pain experience (numerical rating scale)	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 Outcome Measures

Name	Time	Method
Protrusion (distance in mm)	6 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.
Maximum mouth opening (Unit: mm)	6 months	measuring the distance between the incisal edges of the upper and lower central incisors using a ruler. Unit: mm
Lateral excursion (Unit: mm)	6 months	measuring the distance between midline of upper and lower jaws. Unit: mm