Temporomandibular Joint DisordersNCT03576079
Effect of Laser Therapy Versus Anterior Re-positioning Splint in the Treatment of Disc Displacement With Reduction
A study testing Laser therapy, anterior re-positioning splint and inactive Laser therapy in people with Temporomandibular Joint Disorders, run by Cairo University.
Trial summary
comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Laser therapy, anterior re-positioning splint and inactive Laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Jun 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI.
- Good general health: The patient must be medically free from any systemic disease or health problems.
- Adult patients 18 years old and above.
- No previous orthodontic treatment.
- No previous TMJ treatment or surgery.
Who cannot join
- Patients with multiple missing posterior teeth.
- Muscle pain due to systemic disease.
- Dental related pain.
- Congenital abnormality, neoplasia or acute trauma.
- Previous TMJ treatment or surgery.
- Any medical condition that prohibits MRI acquisition.
About this study
Official title: Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial
comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.
Read the detailed description
to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Laser therapy, anterior re-positioning splint, inactive Laser therapy
- Keywords
- laser therapy, anterior re-positioning 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.
Laser therapyDevice
Also called low-level Laser therapy, Biolase laser device
epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
anterior re-positioning splintDevice
Also called occlusal splint, TMD splint
hard acrylic anterior re-positioning splint
inactive Laser therapyDevice
sham Laser, with inactive beam
| Study group | Role | What they receive |
|---|---|---|
| Laser therapy | Experimental | 12 laser sessions over 3 months Receives: Device: Laser therapy |
| anterior re-positioning splint therapy | Active comparator | anterior re-positioning splint worn for 8 hours during night time for 3 months Receives: Device: anterior re-positioning splint |
| inactive laser therapy | Placebo comparator | placebo laser for 12 sessions over 3 months Receives: Device: inactive Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale
current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain
Measured: 3 months
Secondary outcomes (3)
click: joint sound
joint sound., it is a binary measurement assessed by hand palpation
Measured: 3 months
limitation of mandibular movements
mouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper.
Measured: 3 months
disc recapture
change in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y
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 posted3 Jul 2018
- Study start1 Sep 2015
- Primary completion30 Sep 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Elzawahry, Cairo University
- Investigators
- Mona S Fayed, PHD, Study director, Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576079
- Sponsor's protocol ID
- CEBD-CU-2015-02-25
- Status last verified
- Jul 2018
- First submitted
- 9 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Irradiation Versus Anterior Repositioning Splint in Treatment of Disc Displacement With Reduction A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03576079
- Acronym / sponsor ID
- CEBD-CU-2015-02-25
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- laser therapy, anterior re-positioning splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 3 Jul 2018 (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.
comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.
Detailed description
to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser therapy | Experimental | Device: Laser therapy12 laser sessions over 3 months |
| anterior re-positioning splint therapy | Active comparator | Device: anterior re-positioning splintanterior re-positioning splint worn for 8 hours during night time for 3 months |
| inactive laser therapy | Placebo comparator | Device: inactive Laser therapyplacebo laser for 12 sessions over 3 months |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients having TMD in the form of disc displacement with reduction as verified from signs and symptoms during clinical examination and confirmed from the MRI.
- Good general health: The patient must be medically free from any systemic disease or health problems.
- Adult patients 18 years old and above.
- No previous orthodontic treatment.
- No previous TMJ treatment or surgery.
Key exclusion criteria (6 listed)
- Patients with multiple missing posterior teeth.
- Muscle pain due to systemic disease.
- Dental related pain.
- Congenital abnormality, neoplasia or acute trauma.
- Previous TMJ treatment or surgery.
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 |
|---|---|---|
| Laser therapyAlso: low-level Laser therapy, Biolase laser deviceepic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode. | Device | Laser therapy |
| anterior re-positioning splintAlso: occlusal splint, TMD splinthard acrylic anterior re-positioning splint | Device | anterior re-positioning splint therapy |
| inactive Laser therapysham Laser, with inactive beam | Device | inactive laser therapy |
Primary outcome
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale
Time frame: 3 months
current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain
3 secondary outcomes
click: joint sound
Time frame: 3 months
limitation of mandibular movements
Time frame: 3 months
disc recapture
Time frame: 3 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 3 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
Mona S Fayed, PHD study director
Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye
Questions about this trial
What is this clinical trial studying?
A study testing Laser therapy, anterior re-positioning splint and inactive Laser therapy in people with Temporomandibular Joint Disorders, 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 5 inclusion and 6 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 3 Jul 2018. 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. Some participants in this study may receive a placebo. 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?
Level of temporomandibular joint pain: assessed by using subjective visual analogue scale (time frame: 3 months). 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 3 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.