Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .

TMJ Disc Disorder Clinical Trial

Official title:

Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint in Patients With Temporomandibular Joint Anterior Disc Displacement With Reduction . ( Randomized Controlled Clinical Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02960048
• Other study ID #: CairoARS-SRS
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 8, 2016
• Start date: November 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2016
• Source: Cairo University
• Contact: Moataz Nasr, BSC
• Phone: 01000353417
• Email: Motaz_52[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

Description:

To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.

PICO:

Population (P): Patients with symptomatic anterior disc displacement with reduction.

Intervention (I): Michigan splint. Comparator (C): Anterior 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: 60
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Adult patient from 15 to 50 years old.

2. Report of pain in preauricular region worsened by functional activities, such as chewing and talking.

3. Presence of disc displacement with reduction and joint clicking

4. positive diagnosis of unilateral or bilateral anterior disc displacement with reduction by means of magnetic resonance imaging (MRI).

Exclusion Criteria:

1. . .

2. History of TMJ surgery.

3. Individuals with osteoarthritis.

4. Individuals under TMD management.

5. Individuals wearing full or partial dentures.

6. Individuals with major psychological disorders.

7. Nonreducing dislocations of the articular disc

8. Consequences of condyle fractures and/or fracture of another maxillofacial zone.

9. Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis, psoriasis arthritis).

10. Individuals with a recent history of trauma in the face and/or neck area. Individuals with systemic diseases that can affect TMJ

Study Design

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

Related Conditions & MeSH terms

• TMJ Disc Disorder

Intervention

Device:
• 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 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. This area will create the eccentric guidance.
• Anterior repositioning 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (9)

Badel T, Marotti M, Kern J, Laskarin M. A quantitative analysis of splint therapy of displaced temporomandibular joint disc. Ann Anat. 2009 Jun;191(3):280-7. doi: 10.1016/j.aanat.2008.12.004. — View Citation

Conti PC, Corrêa AS, Lauris JR, Stuginski-Barbosa J. Management of painful temporomandibular joint clicking with different intraoral devices and counseling: a controlled study. J Appl Oral Sci. 2015 Oct;23(5):529-35. doi: 10.1590/1678-775720140438. — View Citation

Conti PC, de Azevedo LR, de Souza NV, Ferreira FV. Pain measurement in TMD patients: evaluation of precision and sensitivity of different scales. J Oral Rehabil. 2001 Jun;28(6):534-9. — View 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. Review. — View Citation

Huang IY, Wu JH, Kao YH, Chen CM, Chen CM, Yang YH. Splint therapy for disc displacement with reduction of the temporomandibular joint. part I: modified mandibular splint therapy. Kaohsiung J Med Sci. 2011 Aug;27(8):323-9. doi: 10.1016/j.kjms.2011.03.006. — View Citation

Khare N, Patil SB, Kale SM, Sumeet J, Sonali I, Sumeet B. Normal mouth opening in an adult Indian population. J Maxillofac Oral Surg. 2012 Sep;11(3):309-13. doi: 10.1007/s12663-012-0334-1. — View Citation

Lundh H, Westesson PL, Kopp S, Tillström B. Anterior repositioning splint in the treatment of temporomandibular joints with reciprocal clicking: comparison with a flat occlusal splint and an untreated control group. Oral Surg Oral Med Oral Pathol. 1985 Aug;60(2):131-6. — View Citation

Sharmila devi Devaraj 1 and 2, "Internal Derangement of Temporomandibular Joint - A Review\n," IOSR J. Dent. Med. Sci., vol. 13, no. 3, pp. 66-73, 2014.

T. Badel, V. Lajnert, and D. Zadravec, "Michigan splint and treatment of temporomandibular joint Michiganska udlaga i lijecenje temporomandibularnog zgloba," vol. 49, no. 2, pp. 112-120, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No
Secondary	Maximum mouth opening.	measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm	3 months	No
Secondary	Lateral excursion.	measuring the distance between midline of upper and lower jaws . Unit: mm	3 months	No
Secondary	Protrusion.	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.	3 months	No

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