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

TMJ Disc Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02992379
• Other study ID #: cairo ss-ps
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2016
• Last updated: December 10, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Cairo University
• Contact: hesham M safa, master
• Phone: 01001720677
• Email: Dr.hesham_dent[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

Device:
• pivot splint
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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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 Au — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Maximum mouth opening (Unit: mm)	measuring the distance between the incisal edges of the upper and lower central incisors using a ruler. Unit: mm	6 months	Yes
Secondary	Lateral excursion (Unit: mm)	measuring the distance between midline of upper and lower jaws. Unit: mm	6 months	Yes
Secondary	Protrusion (distance in mm)	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.	6 months	Yes