Temporomandibular DisorderNCT04524806
Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
A study testing stabilization splint in people with Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital.
Trial summary
The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Temporomandibular Joint Disorders, Orofacial Pain
- What is being tested?
- stabilization splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 30 Jan 2015
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No need for orthodontic treatment
- Maximum 2 teeth have been extracted
- Having efficient occlusal contacts
- Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Who cannot join
- Treated with stabilization splint before
- Partial edentulous patients
- Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
About this study
The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.
Read the detailed description
Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.
- Being tested
- stabilization splint
- Keywords
- stabilization splint, temporomandibular disorders, RDC/TMD, temporomandibular joint, orofacial pain
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabilization splintOther
Stabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles
| Study group | Role | What they receive |
|---|---|---|
| 2 mm-thick splint group (2 mm-TSG) | Active comparator | The group which applied the 2 mm thick stabilization splint Receives: Other: stabilization splint |
| 4 mm-thick splint group (4 mm-TSG) | Active comparator | The group which applied the 4 mm thick stabilization splint Receives: Other: stabilization splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of myofascial pain
Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD.
I.a Myofascial pain:
- Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function)
- Pain on palpation in at least 3 sites (There are 20 sites (ten on each side): posterior, middle and anterior Temporalis; origin, body and insertion of Masseter; posterior mandibular region; Submandibular region; lateral Pterygoid; tendon of Temporalis), one of them at least in the same side of the reported pain
I.b Myofascial pain with limited opening:
- Myofascial pain
- Pain-free unassisted 3 opening< 40 mm and Passive 4 stretch ≥ 5 mm
Measured: Up to 6 months
Presence of intra-capsular temporomandibular disorders
II.a Disc displacement with reduction:
- No pain in the joint
- Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click
- With click on opening and closing (unless excursive click confirmed):
- Click on opening occurs at ≥ 5 mm interincisal distance than on closing
- Clicks eliminated by protrusive opening
II.b Disc displacement without reduction with limited opening:
- History of locking or catching that interfered with eating
- Absence of TMJ clicking
- Unassisted opening (even painful) ≤ 35mm and passive stretch ≤ 4mm
- Contralateral excursion < 7mm
II.c Disc displacement without reduction without limited opening:
- History of locking or catching that interfered with eating
- The presence of TMJ sounds excluding DDR clicking
- Unassisted opening (even painful) > 35mm and passive stretch > 4mm
- Contralateral excursion ≥ 7mm
Measured: Up to 6 months
Secondary outcomes (2)
Presence of TMJ sounds
Click: A distinct sound, of brief and very limited duration, with a clear beginning and end, which usually sounds like a "click."
Opening Click: If upon opening and closing from maximum intercuspation, a click is noted on two of three opening movements, record as positive for opening click.
Closing Click: A click present on two of three closing mandibular movements.
Measured: Up to 6 months
Limitation of jaw movements
The researcher places the edge of the millimeter ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measures vertically to the labioincisal edge of the opposing mandibular incisor; records this measurement.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Jul 2013
- Primary completion1 Jan 2014
- Study completion30 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Halenur Bilir, DDS, Study director, Medipol UniversityHanefi Kurt, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524806
- Sponsor's protocol ID
- halenurbilir
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Stabilization Splint Thickness on The Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04524806
- Acronym / sponsor ID
- halenurbilir
- Keywords
- stabilization splint, temporomandibular disorders, RDC/TMD, temporomandibular joint, orofacial pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jan 2014 (actual)
- Study completion
- 30 Jan 2015 (actual)
- First posted
- 24 Aug 2020 (actual)
- 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.
The aim of the study is assessing the effect of the stabilization splint (SS) thickness on the temporomandibular disorder's and their symptoms; such as muscle or temporomandibular joint (TMJ) pain, TMJ sounds, and limitation of mouth opening.
Detailed description
Participants are selected from patients who applied to the clinic with the complaint of temporomandibular disorders (TMDs). Symptoms are evaluated with RDC/TMD forms. Regarding the treatment plan, patients are divided into two groups; 2 mm-thick splint group (2 mm-TSG) and 4 mm-thick splint group (4 mm-TSG). They used SS's at night for 8 hours, and they were recalled on 1st, 2nd, 3rd, and 6th months after splint insertion. Their symptoms and splints are checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 mm-thick splint group (2 mm-TSG) | Active comparator | Other: stabilization splintThe group which applied the 2 mm thick stabilization splint |
| 4 mm-thick splint group (4 mm-TSG) | Active comparator | Other: stabilization splintThe group which applied the 4 mm thick stabilization splint |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No need for orthodontic treatment
- Maximum 2 teeth have been extracted
- Having efficient occlusal contacts
- Patients in the axis 1 and axis 2 groups according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
Key exclusion criteria (3 listed)
- Treated with stabilization splint before
- Partial edentulous patients
- Patients in the axis 3 group according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
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 |
|---|---|---|
| stabilization splintStabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles | Other | 2 mm-thick splint group (2 mm-TSG), 4 mm-thick splint group (4 mm-TSG) |
Primary outcome
Presence of myofascial pain
Time frame: Up to 6 months
Myofascial pain and myofascial pain with limited opening are in the Group I according to the RDC/TMD. I.a Myofascial pain: 1. Reported pain in masticatory muscles (In the jaw, temples, face, preauricular area, or inside the ear, at rest or function) 2. Pain on palpation in at least 3 sites (There are 20 sites (ten on each side): posterior, middle and anterior Temporalis; origin, body and insertion of Masseter; posterior mandibular region; Submandibular region; lateral Pterygoid; tendon of Temporalis), one of them at least in the same side of the reported pain I.b Myofascial pain with limited opening: 1. Myofascial pain 2. Pain-free unassisted 3 opening< 40 mm and Passive 4 stretch ≥ 5 mm
Presence of intra-capsular temporomandibular disorders
Time frame: Up to 6 months
II.a Disc displacement with reduction: 1. No pain in the joint 2. Reproducible (All clicks must be reproduced 2 out of 3 consecutive trials) click on excursion with either opening or closing click 3. With click on opening and closing (unless excursive click confirmed): * Click on opening occurs at ≥ 5 mm interincisal distance than on closing * Clicks eliminated by protrusive opening II.b Disc displacement without reduction with limited opening: 1. History of locking or catching that interfered with eating 2. Absence of TMJ clicking 3. Unassisted opening (even painful) ≤ 35mm and passive stretch ≤ 4mm 4. Contralateral excursion < 7mm II.c Disc displacement without reduction without limited opening: 1. History of locking or catching that interfered with eating 2. The presence of TMJ sounds excluding DDR clicking 3. Unassisted opening (even painful) > 35mm and passive stretch > 4mm 4. Contralateral excursion ≥ 7mm
2 secondary outcomes
Presence of TMJ sounds
Time frame: Up to 6 months
Limitation of jaw movements
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- 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.
Halenur Bilir, DDS study director
Medipol University
Hanefi Kurt, PhD study chair
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing stabilization splint in people with Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital.
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 3 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: finished, as of the sponsor's last update on 24 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of myofascial pain (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2020.