Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .
NCT ID: NCT02960048
Last Updated: 2016-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-11-30
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Moataz Nasr
Oral and maxillofacial surgery resident in Sahel Teaching hospital
Principal Investigators
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Nadia Galal, MD
Role: STUDY_DIRECTOR
Cairo University
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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 liječenje temporomandibularnog zgloba," vol. 49, no. 2, pp. 112-120, 2013.
Related Links
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Related Info
Related Info
Other Identifiers
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CairoARS-SRS
Identifier Type: -
Identifier Source: org_study_id