Temporomandibular Joint Disc DisplacementNCT03057262
The Efficiency of Anterior Repositioning Splint for the Management of Temporomandibular Joint Dysunction
An observational study of Temporomandibular Joint Disc Displacement, run by Jagiellonian University.
Trial summary
Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Disc Displacement
- What is being tested?
- Repositioning splint
- Type of treatment
- Medical device
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Dec 2016
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 112 subjects were included to the study, 83 women and 29 men aged 24-45 years (mean age was 31). The study group includes 40 women and 16 men, and the control group contains 43 women and 13 men.
Who may be able to join
- unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in TMJ(s),
- in the previous 30 days, any TMJ noise(s) present with jaw movement or function,
- unilateral or bilateral pain in the area of temporomandibular joint,
- presence of masticatory muscles contracture,
- full dentition or single tooth loss,
- good general health,
Show all 9Show fewer
- positive mandible protrusion test,
- no contraindications for laser therapy
- patient consent to be involved in the study.
Who cannot join
- partial tooth loss or edentulism,
- contraindications for laser therapy
- absence of appropriate symptoms
- absence of consent to be involved in the study
About this study
Official title: The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction
Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.
Read the detailed description
The research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in Consulting Room of Temporomandibular Joint Dysfunctions at the Jagiellonian University in Cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. Subjects were examined according to the Diagnostic Criteria for Temporomandibular Disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). In the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. In the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. Pain intensity was evaluated using verbal numerical rating scale (VNRS) immediately before the treatment and then after 4 and 16 weeks. The obtained data were analyzed using U Mann-Whitney test (p ≤ 0,005).
- Being tested
- Repositioning splint
- Keywords
- temporomandibular joint disorders, disc displacement with reduction, anterior repositioning splint
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repositioning splintDevice
Application of repositioning splint in the study group.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Study group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the study group was used the typical acrylic anterior repositioning splint fabricated in tete-a-tete (incisal) jaws position, covered the lower teeth arch to recapture a displaced disc(s) and decrease the intensity of pain. The anterior repositioning splint was recommended to 20 - hour use for a period of four months. Receives: Device: Repositioning splint | |
| Control group | Control group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the control group the investigators used the biostymulation laser (Terapus 2, Accuro, Poland), wave length 808 nm, power 32 J in the form of 12 session (duration of a single session was 3 min 45 s), performed every second day, on the area of the both temporomandibular joints (distance to the skin was 1 cm) with opened mouth and systematic performing of muscles self-exercises with a dominant protrusive position of mandible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief related to temporomandibular joint disc displacement with reduction
Repositioning splint was applied to check its efficiency of pain relieving in a case of temporomandibular joint disc displacement with reduction.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Disc DisplacementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malgorzata Pihut, Jagiellonian University
- Investigators
- Malgorzata Pihut, DDS, PhD, Study director, Jagiellonian UniversityMalgorzata Gorecka, DDS, Principal investigator, Jagiellonian UniversityPiotr Ceranowicz, MD, PhD, Study chair, Jagiellonian UniversityMieszko Wieckiewicz, DMD, PhD, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057262
- Sponsor's protocol ID
- 122.6120.43.2016 BC
- Status last verified
- Mar 2017
- First submitted
- 15 Feb 2017
- Last updated
- 21 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Pihut M, Gorecka M, Ceranowicz P, Wieckiewicz M. The Efficiency of Anterior Repositioning Splints in the Management of Pain Related to Temporomandibular Joint Disc Displacement with Reduction. Pain Res Manag. 2018 Feb 21;2018:9089286. doi: 10.1155/2018/9089286. eCollection 2018.
PubMed 29682131
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Anterior Repositioning Splint for the Management of Pain Related to Temporomandibular Joint Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT03057262
- Acronym / sponsor ID
- 122.6120.43.2016 BC
- Keywords
- temporomandibular joint disorders, disc displacement with reduction, anterior repositioning splint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Feb 2017 (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.
Intra-articular temporomandibular disorders are often related to pain in the area of temporomandibular joint, ear and temple. The aim of the study was to investigate the efficiency of anterior repositioning splints for the management of pain related to temporomandibular joint disc displacement with reduction.
Detailed description
The research material consisted of 112 patients, aged 24 to 45 years, of both genders, who reported to the treatment in Consulting Room of Temporomandibular Joint Dysfunctions at the Jagiellonian University in Cracow, between 2014-2016, due to the pain and clicking of temporomandibular joints with comorbid hypertension of masticatory muscles. Subjects were examined according to the Diagnostic Criteria for Temporomandibular Disorders protocol and after inclusion with painful disc displacement with reduction and masticatory muscle contracture assigned randomly to the study or control group (56 patients in each). In the study group was used the anterior repositioning splint on the lower arch for 20 hour usage per 4 months. In the control group a non-invasive therapy was applied using biostimulation laser in the form of 12 session, performed every second day, on the area of the temporomandibular joints with opened mouth and performing muscles self-exercises with a dominant protrusive position of the mandible. Pain intensity was evaluated using verbal numerical rating scale (VNRS) immediately before the treatment and then after 4 and 16 weeks. The obtained data were analyzed using U Mann-Whitney test (p ≤ 0,005).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Repositioning splintStudy group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the study group was used the typical acrylic anterior repositioning splint fabricated in tete-a-tete (incisal) jaws position, covered the lower teeth arch to recapture a displaced disc(s) and decrease the intensity of pain. The anterior repositioning splint was recommended to 20 - hour use for a period of four months. |
| Control group | – | –Control group consisted of 56 subjects of both genders with unilateral or bilateral disc displacement(s) with reduction and pain in the area of temporomandibular joint. Patients were recruited from the Consulting Room of Temporomandibular Joint Dysfunction at the Jagiellonian University in Krakow during the years 2014-2016. In the control group the investigators used the biostymulation laser (Terapus 2, Accuro, Poland), wave length 808 nm, power 32 J in the form of 12 session (duration of a single session was 3 min 45 s), performed every second day, on the area of the both temporomandibular joints (distance to the skin was 1 cm) with opened mouth and systematic performing of muscles self-exercises with a dominant protrusive position of mandible. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 112 subjects were included to the study, 83 women and 29 men aged 24-45 years (mean age was 31). The study group includes 40 women and 16 men, and the control group contains 43 women and 13 men.
Key inclusion criteria (9 listed)
- unilateral or bilateral presence of clicking, popping and/or snapping noise(s) detected with palpation during opening or closing or lateral or protrusive movements in TMJ(s),
- in the previous 30 days, any TMJ noise(s) present with jaw movement or function,
- unilateral or bilateral pain in the area of temporomandibular joint,
- presence of masticatory muscles contracture,
- full dentition or single tooth loss,
Key exclusion criteria (4 listed)
- partial tooth loss or edentulism,
- contraindications for laser therapy
- absence of appropriate symptoms
- absence of consent to be involved in the study
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 |
|---|---|---|
| Repositioning splintApplication of repositioning splint in the study group. | Device | Study group |
Primary outcome
Pain relief related to temporomandibular joint disc displacement with reduction
Time frame: 16 weeks
Repositioning splint was applied to check its efficiency of pain relieving in a case of temporomandibular joint disc displacement with reduction.
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 21 Mar 2017.
- Derived from this study: PubMed 29682131Pihut M, Gorecka M, Ceranowicz P, Wieckiewicz M. The Efficiency of Anterior Repositioning Splints in the Management of Pain Related to Temporomandibular Joint Disc Displacement with Reduction. Pain Res Manag. 2018 Feb 21;2018:9089286. doi: 10.1155/2018/9089286. eCollection 2018.
- 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.
Malgorzata Pihut, DDS, PhD study director
Jagiellonian University
Malgorzata Gorecka, DDS principal investigator
Jagiellonian University
Piotr Ceranowicz, MD, PhD study chair
Jagiellonian University
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disc Displacement, run by Jagiellonian 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 9 inclusion and 4 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 21 Mar 2017. 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?
Pain relief related to temporomandibular joint disc displacement with reduction (time frame: 16 weeks). 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 NCT03057262, which also lists 1 linked publication.
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 21 Mar 2017.