Temporomandibular DisordersTMDNCT01659840
Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders
A study testing Red laser and Infrared laser in people with Temporomandibular Disorders, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Red laser and Infrared laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Nov 2010
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- systemic health;
- Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
- pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)
Who cannot join
- participants who made frequent use of analgesics, NSAIDs and antidepressants;
- patients with previously undergone TMD treatment, or suffered facial trauma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Periodontics Clinic, Department of Dentistry
Diamantina, Minas Gerais, 39100000
About this study
Official title: Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial
The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients
Read the detailed description
The aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD patients.
- Conditions
- Temporomandibular Disorders
- Being tested
- Red laser, Infrared laser
- Keywords
- laser,, quality of life,, 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.
Red laserRadiation
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
Infrared laserRadiation
On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
| Study group | Role | What they receive |
|---|---|---|
| Red laser | Other | On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. Receives: Radiation: Red laser |
| Infrared laser | Other | On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. Receives: Radiation: Infrared laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain points of muscle and articulation
Measured: 180 days
Secondary outcomes (1)
Quality of life
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Flecha, Federal University of São Paulo
- Investigators
- Olga D Flecha, Professor, Principal investigator, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659840
- Sponsor's protocol ID
- senhaodf
- Acronym
- TMD
- Status last verified
- Aug 2012
- First submitted
- 6 Aug 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Red and Infrared Lasers in Treatment of Temporomandibular Disorders - A Double-blind, Randomized, Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT01659840
- Acronym / sponsor ID
- TMD / senhaodf
- Conditions
- Temporomandibular Disorders
- Keywords
- laser,, quality of life,, orofacial pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Aug 2012 (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.
The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients
Detailed description
The aim of the present study was to evaluate and compare the efficacy of red (600nm) and infrared (800nm) laser therapy in relieving pain and improving the quality of life of TMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Red laser | Other | Radiation: Red laserOn the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. |
| Infrared laser | Other | Radiation: Infrared laserOn the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- systemic health;
- Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
- pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)
Key exclusion criteria (2 listed)
- participants who made frequent use of analgesics, NSAIDs and antidepressants;
- patients with previously undergone TMD treatment, or suffered facial trauma
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 laserOn the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. | Radiation | Red laser |
| Infrared laserOn the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications. | Radiation | Infrared laser |
Primary outcome
pain points of muscle and articulation
Time frame: 180 days
1 secondary outcome
Quality of life
Time frame: 180 days
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 8 Aug 2012.
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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.
Olga D Flecha, Professor principal investigator
Federal University of the Valleys of Jequitinhonha and Mucuri
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 laser and Infrared laser in people with Temporomandibular Disorders, run by Federal University of São 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 3 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 8 Aug 2012. 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?
pain points of muscle and articulation (time frame: 180 days). 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 8 Aug 2012.