Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
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ClinicalTrials.gov Identifier: NCT03257748 |
Recruitment Status :
Recruiting
First Posted : August 22, 2017
Last Update Posted : October 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder | Radiation: Laser Therapy Radiation: LED therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial |
Actual Study Start Date : | May 1, 2017 |
Estimated Primary Completion Date : | November 20, 2018 |
Estimated Study Completion Date : | December 20, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: LED group
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
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Radiation: LED therapy
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. |
Experimental: Laser group
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
|
Radiation: Laser Therapy
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. |
- Visual Analog Scale [ Time Frame: Through study completion, an average of 1 year. ]This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
- Visual Analog Scale [ Time Frame: Through study completion, an average of 1 year. ]This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
- Maximum vertical mandibular movement [ Time Frame: Through study completion, an average of 1 year. ]Maximum vertical mandibular movement: The volunteer will be instructed to open his/her mouth a wide as possible. Maximum vertical mandibular movement will be measured as the distance between the maxillary and mandibular central incisors determined with the aid of digital calipers. The volunteer will then be instructed to exert pressure on the mandibular teeth with the mouth open and move the mandible to the right and left for the determination of excursion (distance between upper and lower mid points). These procedures will be performed before and immediately after treatment.
- Muscle tension [ Time Frame: Through study completion, an average of 1 year. ]Muscle tension: Palpation will be performed of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscle. The classification proposed by Jensen et al. will be used, with the following scores: 0 = absence of pain; 1 = mild discomfort; 2 = moderate pain; and 3 = severe pain. These procedures will be performed before and immediately after treatment.
- Electromyography [ Time Frame: Through study completion, an average of 1 year. ]The electrical signals of the right and left masseter and anterior temporal muscles will be captured. The EMG signal will be determined using a four-channel acquisition system (EMG System do Brasil Ltda.) with a sampling frequency of 2 KHz. The signal will be digitized using an analog-to-digital converter with 16 bits of resolution. The EMGLab (EMG System do Brasil Ltda) will be employed as the acquisition system. These procedures will be performed before and immediately after treatment.

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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Clinical diagnosis of TMD based on the RDC/TMD;
- Age between 40 and 70 years.
Exclusion Criteria:
- Dentofacial anomalies;
- Currently in orthodontic or orthopedic treatment for the jaw;
- Currently undergoing physical therapy;
- Currently undergoing psychological treatment;
- Use of muscle relaxant or anti-inflammatory agent.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257748
Contact: Sandra K Bussadori, PhD | +55 11 26339000 | sandra.skb@gmail.com | |
Contact: Luciana G Langella, Ms | +55 11 26339000 | lucianalangella@hotmail.com |
Brazil | |
UniNove | Recruiting |
São Paulo, SP, Brazil, 01504001 | |
Contact: Sandra K Bussadori, Ms +55 11 26339000 sandra.skb@gmail.com |
Principal Investigator: | Sandra K Bussadori, PhD | University of Nove de Julho |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho |
ClinicalTrials.gov Identifier: | NCT03257748 History of Changes |
Other Study ID Numbers: |
DTMLU |
First Posted: | August 22, 2017 Key Record Dates |
Last Update Posted: | October 11, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Disease Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Craniomandibular Disorders Mandibular Diseases Jaw Diseases |
Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases Pathologic Processes Myofascial Pain Syndromes |