Clinical trial NCT02960048: Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TMJ Disc Disorder
Keywords: Anterior disc displacement
TMD therapy
internal derangement
occlusal splint
anterior repositioning splint
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' subjective pain experience.
timeFrame: 3 months
Secondary outcomes:
measure: Maximum mouth opening.
timeFrame: 3 months
measure: Lateral excursion.
timeFrame: 3 months
measure: Protrusion.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nadia Galal, MD
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.
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. Epub 2011 May 10.
citation: Lundh H, Westesson PL, Kopp S, Tillstrom 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. doi: 10.1016/0030-4220(85)90280-4.
citation: 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. Epub 2009 Feb 12.
citation: Conti PC, Correa 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. Epub 2015 Jul 21.
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. doi: 10.1046/j.1365-2842.2001.00727.x.
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. Epub 2012 Feb 19.
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.
citation: T. Badel, V. Lajnert, and D. Zadravec, "Michigan splint and treatment of temporomandibular joint Michiganska udlaga i liječenje temporomandibularnog zgloba," vol. 49, no. 2, pp. 112-120, 2013.