NCT02960048

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 9, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

November 7, 2016

Last Update Submit

November 8, 2016

Conditions

TMJ Disc Disorder

Keywords

Anterior disc displacementTMD therapyinternal derangementocclusal splintanterior repositioning splint

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Maximum mouth opening.

    3 months

  • Lateral excursion.

    3 months

  • Protrusion.

    3 months

Study Arms (2)

Anterior repositioning splint

ACTIVE COMPARATOR

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.

Device: Anterior repositioning splint

Stabilizing splint

EXPERIMENTAL

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.

Device: Stabilizing splint

Interventions

Stabilizing splintDEVICE

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.

Also known as: Michigan-type occlusal splint
Stabilizing splint
Anterior repositioning splintDEVICE

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.

Also known as: ARS
Anterior repositioning splint

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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:

  • History of TMJ surgery.
  • Individuals with osteoarthritis.
  • Individuals under TMD management.
  • Individuals wearing full or partial dentures.
  • Individuals with major psychological disorders.
  • Nonreducing dislocations of the articular disc
  • Consequences of condyle fractures and/or fracture of another maxillofacial zone.
  • 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. Individuals with systemic diseases that can affect TMJ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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: 22855899BACKGROUND

  • 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.

    PMID: 21802643BACKGROUND

  • 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.

    PMID: 3862019BACKGROUND

  • 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.

    PMID: 19282162BACKGROUND

  • 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.

    PMID: 26200526BACKGROUND

  • 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.

    PMID: 11422679BACKGROUND

  • 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.

    PMID: 23997482BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Related Links

Study Officials

  • Nadia Galal, MD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Moataz Nasr, BSC

CONTACT

01000353417Motaz_52@yahoo.com

Omniya Abdelaziz, Lecturer

CONTACT

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
Oral and maxillofacial surgery resident in Sahel Teaching hospital

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

November 9, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share