TMJ Disc DisorderNCT02960048
Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint .
A study testing Stabilizing splint and Anterior repositioning splint in people with TMJ Disc Disorder, run by Cairo University.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- Stabilizing splint and Anterior repositioning splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- . .
- History of TMJ surgery.
- Individuals with osteoarthritis.
- Individuals under TMD management.
- Individuals wearing full or partial dentures.
- Individuals with major psychological disorders.
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Omniya Abdelaziz, Lecturer contact
About this study
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)
To evaluate the effectiveness of Michigan-type occlusal splint and anterior repositioning splint in patients with temporomandibular joint anterior disc displacement with reduction.
Read the 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:
- 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.
- lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws
- 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
- TMJ Disc Disorder
- Being tested
- Stabilizing splint, Anterior repositioning splint
- Keywords
- Anterior disc displacement, TMD therapy, internal derangement, occlusal splint, anterior repositioning splint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilizing splintDevice
Also called Michigan-type occlusal 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 splintDevice
Also called ARS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Stabilizing splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Maximum mouth opening.
measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm
Measured: 3 months
Lateral excursion.
measuring the distance between midline of upper and lower jaws . Unit: mm
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moataz Nasr, Cairo University
- Investigators
- Nadia Galal, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960048
- Sponsor's protocol ID
- CairoARS-SRS
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22855899Huang 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.
PubMed 21802643Lundh 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.
PubMed 3862019Badel 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.
PubMed 19282162Conti 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.
PubMed 26200526Conti 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.
PubMed 11422679Khare 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.
PubMed 23997482Sharmila 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02960048
- Acronym / sponsor ID
- CairoARS-SRS
- Conditions
- TMJ Disc Disorder
- Keywords
- Anterior disc displacement, TMD therapy, internal derangement, occlusal splint, anterior repositioning splint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- lateral excursion . Assessment of lateral excursion will be performed by measuring the distance in mm between midline of upper and lower jaws
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior repositioning splint | Active comparator | Device: Anterior repositioning splintA 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 | Experimental | Device: Stabilizing splintA 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- . .
- History of TMJ surgery.
- Individuals with osteoarthritis.
- Individuals under TMD management.
- Individuals wearing full or partial dentures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilizing splintAlso: Michigan-type occlusal splintA 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 |
| Anterior repositioning splintAlso: ARSA 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 |
Primary outcome
Patients' subjective pain experience.
Time frame: 3 months
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 secondary outcomes
Maximum mouth opening.
Time frame: 3 months
Lateral excursion.
Time frame: 3 months
Protrusion.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Background: PubMed 22855899Ebrahim 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.
- Background: PubMed 21802643Huang 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.
- Background: PubMed 3862019Lundh 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.
- Background: PubMed 19282162Badel 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.
- Background: PubMed 26200526Conti 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.
- Background: PubMed 11422679Conti 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.
- Background: PubMed 23997482Khare 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.
- BackgroundSharmila 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.
- BackgroundT. 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 InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omniya Abdelaziz, Lecturer contact
Nadia Galal, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Stabilizing splint and Anterior repositioning splint in people with TMJ Disc Disorder, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moataz Nasr, BSC (01000353417, Motaz_52@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' subjective pain experience. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960048, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.