Temporomandibular DisorderLED/TMDNCT01873937
Analgesic Effects of LED Light on Temporomandibular Disorders.
A study testing Red LED, INFRARED LED and LASER in people with Temporomandibular Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Red LED, INFRARED LED and LASER
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2009to Dec 2009
- 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
- Thirty patients (from 18 to 50 years old) presenting signs and symptoms of TMD were selected to participate in the study. The patients received care at a private dental office in Ribeirao Preto, São Paulo, Brazil (NILO- Integrated Center for Laser in Dentistry). The patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the TMJ area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.
Who cannot join
- The exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids.
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
NILO- Integrated Center for Laser in Dentistry
Ribeirão Preto, São Paulo
About this study
Official title: COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY
Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.
Read the detailed description
Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Method: This study proposes an evaluation of analgesic effect in TMD (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared LED, red LED and Control Group using infrared Laser).
- Conditions
- Temporomandibular Disorder
- Being tested
- Red LED, INFRARED LED, LASER
- Keywords
- Lasertherapy, Ledtherapy, TMJs, pain relief, oral aperture
- 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.
Red LEDRadiation
Also called Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Phototherapy with red LED on temporomandibular area
INFRARED LEDRadiation
Also called Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
Phototherapy with infrared LED on temporomandibular area
LASERRadiation
Also called Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
Phototherapy with LASER INFRARED on temporomandibular area
| Study group | Role | What they receive |
|---|---|---|
| Red LED | Experimental | Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point. Receives: Radiation: Red LED |
| infrared LED | Experimental | Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point Receives: Radiation: INFRARED LED |
| LASER | Active comparator | Irradiation parameters: 780 nm, 60 sec and 105 J/cm² Receives: Radiation: LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationships between pain and range of motion
Pain score and mandibular range of motion
Measured: 2 months
Secondary outcomes (1)
Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM)
RDC/DTM diagnostic exam for research of arthralgia and chronic myofascial pain. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the temporomandibular joint, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, University of Sao Paulo
- Investigators
- Panhóca H Panhóca, MS, Principal investigator, IFSC/UFSCARRosane Z Lizarelli, PhD, Study director, University of São Paulo, IFSCVanderlei S Bagnato, PhD, Study director, University of São Paulo, IFSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873937
- Sponsor's protocol ID
- 1967
- Acronym
- LED/TMD
- Status last verified
- Jul 2013
- First submitted
- 29 May 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vinck E, Coorevits P, Cagnie B, De Muynck M, Vanderstraeten G, Cambier D. Evidence of changes in sural nerve conduction mediated by light emitting diode irradiation. Lasers Med Sci. 2005;20(1):35-40. doi: 10.1007/s10103-005-0333-2. Epub 2005 May 14.
PubMed 15895289Whelan HT, Connelly JF, Hodgson BD, Barbeau L, Post AC, Bullard G, Buchmann EV, Kane M, Whelan NT, Warwick A, Margolis D. NASA light-emitting diodes for the prevention of oral mucositis in pediatric bone marrow transplant patients. J Clin Laser Med Surg. 2002 Dec;20(6):319-24. doi: 10.1089/104454702320901107.
PubMed 12513918Hansson TL. Infrared laser in the treatment of craniomandibular disorders, arthrogenous pain. J Prosthet Dent. 1989 May;61(5):614-7. doi: 10.1016/0022-3913(89)90287-4.
PubMed 2746531Oz S, Gokcen-Rohlig B, Saruhanoglu A, Tuncer EB. Management of myofascial pain: low-level laser therapy versus occlusal splints. J Craniofac Surg. 2010 Nov;21(6):1722-8. doi: 10.1097/SCS.0b013e3181f3c76c.
PubMed 21119408
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY
- ClinicalTrials.gov ID
- NCT01873937
- Acronym / sponsor ID
- LED/TMD / 1967
- Conditions
- Temporomandibular Disorder
- Keywords
- Lasertherapy, Ledtherapy, TMJs, pain relief, oral aperture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Jun 2013 (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.
Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.
Detailed description
Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Method: This study proposes an evaluation of analgesic effect in TMD (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared LED, red LED and Control Group using infrared Laser).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red LED | Experimental | Radiation: Red LEDIrradiation parameters: 630 nm, 60 sec and 18 J/cm² per point. |
| infrared LED | Experimental | Radiation: INFRARED LEDIrradiation parameters: 850 nm, 60 sec and 18J/cm² per point |
| LASER | Active comparator | Radiation: LASERIrradiation parameters: 780 nm, 60 sec and 105 J/cm² |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Thirty patients (from 18 to 50 years old) presenting signs and symptoms of TMD were selected to participate in the study. The patients received care at a private dental office in Ribeirao Preto, São Paulo, Brazil (NILO- Integrated Center for Laser in Dentistry). The patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the TMJ area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.
Key exclusion criteria (2 listed)
- The exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids.
- -
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 |
|---|---|---|
| Red LEDAlso: Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.Phototherapy with red LED on temporomandibular area | Radiation | Red LED |
| INFRARED LEDAlso: Irradiation parameters: 850 nm, 60 sec and 18J/cm² per pointPhototherapy with infrared LED on temporomandibular area | Radiation | infrared LED |
| LASERAlso: Irradiation parameters: 780 nm, 60 sec and 105 J/cm²Phototherapy with LASER INFRARED on temporomandibular area | Radiation | LASER |
Primary outcome
Relationships between pain and range of motion
Time frame: 2 months
Pain score and mandibular range of motion
1 secondary outcome
Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM)
Time frame: 2 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 15 Jul 2013.
- Results publication: PubMed 15895289Vinck E, Coorevits P, Cagnie B, De Muynck M, Vanderstraeten G, Cambier D. Evidence of changes in sural nerve conduction mediated by light emitting diode irradiation. Lasers Med Sci. 2005;20(1):35-40. doi: 10.1007/s10103-005-0333-2. Epub 2005 May 14.
- Results publication: PubMed 12513918Whelan HT, Connelly JF, Hodgson BD, Barbeau L, Post AC, Bullard G, Buchmann EV, Kane M, Whelan NT, Warwick A, Margolis D. NASA light-emitting diodes for the prevention of oral mucositis in pediatric bone marrow transplant patients. J Clin Laser Med Surg. 2002 Dec;20(6):319-24. doi: 10.1089/104454702320901107.
- Results publication: PubMed 2746531Hansson TL. Infrared laser in the treatment of craniomandibular disorders, arthrogenous pain. J Prosthet Dent. 1989 May;61(5):614-7. doi: 10.1016/0022-3913(89)90287-4.
- Results publication: PubMed 21119408Oz S, Gokcen-Rohlig B, Saruhanoglu A, Tuncer EB. Management of myofascial pain: low-level laser therapy versus occlusal splints. J Craniofac Surg. 2010 Nov;21(6):1722-8. doi: 10.1097/SCS.0b013e3181f3c76c.
- Related InfoLink provided by the sponsor.
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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.
Panhóca H Panhóca, MS principal investigator
IFSC/UFSCAR
Rosane Z Lizarelli, PhD study director
University of São Paulo, IFSC
Vanderlei S Bagnato, PhD study director
University of São Paulo, IFSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red LED, INFRARED LED and LASER in people with Temporomandibular Disorder, run by University of Sao Paulo at 1 site in Brazil.
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 1 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 15 Jul 2013. 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 Brazil. 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?
Relationships between pain and range of motion (time frame: 2 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 NCT01873937, which also lists 4 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 15 Jul 2013.