TMJ Disc DisorderNCT05548894
Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction
A study testing stabilization splint, laser therapy and stabilization splint and laser therapy in people with TMJ Disc Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- stabilization splint, laser therapy and stabilization splint and laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2021to 6 Mar 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of chronic closed lock patients
- Must not be able to open their mouth
Who cannot join
- neurologic diseases
- TMJ pathologic lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.
Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.
Read the detailed description
Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction.
Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.
- Conditions
- TMJ Disc Disorder
- Being tested
- stabilization splint, laser therapy, stabilization splint and laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabilization splintDevice
Also called upper acrylic full arch splint
upper acrylic splint rest on the maxillary teeth and had flat surface
laser therapyDevice
Also called Low-level laser therapy
The laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism
stabilization splint and laser therapyDevice
Also called splint combined with low level laser therapy
the stabilization splint used in combination of treatment with laser therapy
| Study group | Role | What they receive |
|---|---|---|
| stabilization splint | Active comparator | acrylic splint in the maxillary arch with flat surface Receives: Device: stabilization splint |
| laser therapy | Active comparator | laser beam directed to the affected part cause activation of blood circulation Receives: Device: laser therapy |
| stabilization splint and laser therapy | Active comparator | using both laser therapy and stabilization splint for more improvement Receives: Device: stabilization splint and laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of mouth opening
improvement in mouth opening or not
Measured: 6 months
Masticatory muscles palpation
the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas
Measured: 6 months
temporomandibular joint palpation
joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted
two seconds over the condyle in front of the tragus
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start3 Mar 2021
- Primary completion6 Feb 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel clinical trial
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noha Elshahid, Principal investigator, lecturer at mansoura university prosthodontic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548894
- Sponsor's protocol ID
- A34080622
- Status last verified
- Aug 2022
- First submitted
- 11 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ooi K, Yura S, Inoue N, Totsuka Y. Factors related to the incidence of anterior disc displacement without reduction and bony changes of the temporomandibular joint in patients with anterior open bite. Oral Maxillofac Surg. 2014 Dec;18(4):397-401. doi: 10.1007/s10006-013-0424-3. Epub 2013 Jul 9.
PubMed 23835639Samdal F, Amland PF, Sandsmark M, Hall C, Aasen AO. Suction-assisted lipectomy does not increase the risk of random flap necrosis in a randomized study in pigs. Aesthetic Plast Surg. 1995 Nov-Dec;19(6):549-53. doi: 10.1007/BF00454320.
PubMed 8638492El-Shaheed NH, Mostafa AZH, Aboelez MA. Efficacy of stabilisation splint and low-level laser therapy for patients with chronic closed lock from non-reducible displaced temporo-mandibular joint discs: A parallel randomised clinical trial. J Oral Rehabil. 2023 Mar;50(3):177-193. doi: 10.1111/joor.13405. Epub 2023 Jan 5.
PubMed 36564950
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Efficacy of Stabilization Splint and Low Level Laser Therapy for Treatment of Patients With Chronic Closed Lock of the Non-reducible Temporo-mandibular Joint Disc. A Parallel Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05548894
- Acronym / sponsor ID
- A34080622
- Conditions
- TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 22 Sep 2022 (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.
Stabilization splint therapy and Low-level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low-level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low- level laser therapy, group II received low - level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention.
Detailed description
Objectives: Stabilization splint therapy and low- level laser therapy may serve as non-invasive intervention for painful temporomandibular disorders, but its efficacy is still debated. This study compared the effect of stabilization splint and low- level laser therapy alone or in combination in patients with painful chronic closed lock of temporomandibular joints disc displacement without Reduction.
Patients and methods: 42 patients diagnosed with chronic closed lock of disc displacement without reduction were allocated equally and randomly into three treatment groups: group I received combined stabilization splint and low-level laser therapy, group II received low-level laser therapy and group III received stabilization splint. They were evaluated at baseline and one week, two weeks, four weeks, three months, and six months after the intervention. Time of being normal was also evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| stabilization splint | Active comparator | Device: stabilization splintacrylic splint in the maxillary arch with flat surface |
| laser therapy | Active comparator | Device: laser therapylaser beam directed to the affected part cause activation of blood circulation |
| stabilization splint and laser therapy | Active comparator | Device: stabilization splint and laser therapyusing both laser therapy and stabilization splint for more improvement |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic closed lock patients
- Must not be able to open their mouth
Key exclusion criteria (2 listed)
- neurologic diseases
- TMJ pathologic lesions
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 splintAlso: upper acrylic full arch splintupper acrylic splint rest on the maxillary teeth and had flat surface | Device | stabilization splint |
| laser therapyAlso: Low-level laser therapyThe laser apparatus had a hand piece on which either a specially designed optic prism was attached to transfer laser energy to the tip of the prism | Device | laser therapy |
| stabilization splint and laser therapyAlso: splint combined with low level laser therapythe stabilization splint used in combination of treatment with laser therapy | Device | stabilization splint and laser therapy |
Primary outcome
evaluation of mouth opening
Time frame: 6 months
improvement in mouth opening or not
Masticatory muscles palpation
Time frame: 6 months
the masticatory muscles were palpated bilaterally with firm and constant pressure of one kg lasted two seconds to define painful areas
temporomandibular joint palpation
Time frame: 6 months
joint pain was achieved by first palpating the temporomandibular joint lateral pole by placing the index finger with firm and constant pressure of half kg lasted two seconds over the condyle in front of the tragus
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 27 Sep 2022.
- Background: PubMed 23835639Ooi K, Yura S, Inoue N, Totsuka Y. Factors related to the incidence of anterior disc displacement without reduction and bony changes of the temporomandibular joint in patients with anterior open bite. Oral Maxillofac Surg. 2014 Dec;18(4):397-401. doi: 10.1007/s10006-013-0424-3. Epub 2013 Jul 9.
- Background: PubMed 8638492Samdal F, Amland PF, Sandsmark M, Hall C, Aasen AO. Suction-assisted lipectomy does not increase the risk of random flap necrosis in a randomized study in pigs. Aesthetic Plast Surg. 1995 Nov-Dec;19(6):549-53. doi: 10.1007/BF00454320.
- Derived from this study: PubMed 36564950El-Shaheed NH, Mostafa AZH, Aboelez MA. Efficacy of stabilisation splint and low-level laser therapy for patients with chronic closed lock from non-reducible displaced temporo-mandibular joint discs: A parallel randomised clinical trial. J Oral Rehabil. 2023 Mar;50(3):177-193. doi: 10.1111/joor.13405. Epub 2023 Jan 5.
- Individual participant dataSharing planned: No
Related trials for TMJ Disc Disorder
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Not yet recruiting
Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ
TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction
Not yet recruiting
a Comparison of the Outcomes Following Intra-articular Dextrose 5% Injection Versus Arthrocentesis in Patients With Anterior Disc Displacement With Reduction of the Tomporomandibular Joint
TMJ Disc Disorder
Not yet recruitingPhase 2/3
Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial
TMJ Disc Disorder
Not yet recruitingPhase 2/3
Therapeutic Effect of Proliferative Therapy (Prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients With Anterior Disc Displacement With Reduction: A Randomized Clinical Trial .
TMJ Disc Disorder
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.
Noha Elshahid principal investigator
lecturer at mansoura university prosthodontic department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stabilization splint, laser therapy and stabilization splint and laser therapy in people with TMJ Disc Disorder, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 2 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 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
evaluation of mouth opening (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT05548894, which also lists 3 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 27 Sep 2022; AzTrials last refreshed its copy on 31 Oct 2026.