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

NCT02992379 | Unknown

• 1 other identifier: cairo ss-ps
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

TMJ Disc Disorder

Keywords

Anterior disc displacement; Stabilizing splint

Outcome Measures

Primary Outcomes (1)

• Patients' subjective pain experience (numerical rating scale)

  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.

  6 months

Secondary Outcomes (3)

• Maximum mouth opening (Unit: mm)

  6 months

• Lateral excursion (Unit: mm)

  6 months

• Protrusion (distance in mm)

  6 months

Study Arms (2)

stabilizing splint

ACTIVE COMPARATOR

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

Device: pivot splint; Device: stabilizing splint

pivot splint

EXPERIMENTAL

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

Device: pivot splint; Device: stabilizing splint

Interventions

pivot splint DEVICE

A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of selfcuring 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.

Also known as: PS

pivot splint; stabilizing splint

stabilizing splint DEVICE

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

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 22855899 RESULT

Study Officials

• Nadia Galal, Ass.prof

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

hesham M safa, master

CONTACT

01001720677; Dr.hesham_dent@hotmail.com

Omniya Abdelaziz, lecturer

CONTACT

01001203583; omniya.abdelaziz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at National Cancer Institute

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 14, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share