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A clinical study on the effects of treating temporomandibular disorder (TMD) by low level laser therapy (LLLT), conservative and combination treatments

A clinical study on the effects of treating temporomandibular disorder patients using low level laser therapy , conservative and combination treatments on mouth opening, pain intensity ,temporomandibular joint sounds , serum IL-6, IL-8 and high sensitive C reactive protein.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000442909
Enrollment
33
Registered
2020-04-06
Start date
2020-03-15
Completion date
2020-06-30
Last updated
2021-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The long term goal of this project is to produce a clinically applicable model of treatment which is able to improve the risky condition of TMJ pain, to overcome patients’ complaints and to improve their life quality. One more important reason is to make clear treatment protocol to be followed by physicians during treating TMD and monitoring treatment through assessment of biomarkers. The aim of the study is to compare the effect of treating TMD by low level laser therapy (LLLT) and standard conservative treatment(home based exercise therapy) either separately or combined together. we hypothesized that the effect of low level laser therapy combined with Conservative treatment (home based exercise therapy) on treating temporomandibular disorder will be better than using each treatment modality separately.

Interventions

arm 1 Low level laser therapy: Patients in this group will be treated with 5 sessions of low level laser every other day for duration of 10 days. Ezlase biolase diode laser therapy system, a Class IV laser product, producing contentious GaAlAs, InGaAsPlaser will be utilized in the study. (wavelength: 940 nm, mean output power: 7 W, duration: 24 s, dosage: 60 J/cm2) will be applied to 5 points ( origin of Masseter muscle).Temporal area(Temporalis), insertion of Masseter muscle( angle of mand

arm 1 Low level laser therapy: Patients in this group will be treated with 5 sessions of low level laser every other day for duration of 10 days. Ezlase biolase diode laser therapy system, a Class IV laser product, producing contentious GaAlAs, InGaAsPlaser will be utilized in the study. (wavelength: 940 nm, mean output power: 7 W, duration: 24 s, dosage: 60 J/cm2) will be applied to 5 points ( origin of Masseter muscle).Temporal area(Temporalis), insertion of Masseter muscle( angle of mandible ), preauricular( TMJ) . post auricular ( over mastoid are) . The subjects and the clinician will use protective eyeglasses. Laser probe will be applied 2 cm away from the skin surface. The laser beam will be delivered through a handheld single laser probe. Each point will be exposed to laser beam for 24 s . The outcome measures will be evaluated before the commencements of laser treatment, after the last session of laser treatment, 4 weeks, 8 weeks ,12 weeks after the last session of the treatment arm 2: home based exercises therapy Patients in this group; conservative treatment group will be provided with the standard conservative treatment for temporomandibular disorder (diet and stress counselling, jaw exercises, physical therapy e.g. hot towel application ) by principal investigator (PHD candidate) each patient will go through two face to face training sessions on written instructions for 30 minutes each session, one session before starting treatment and second session will be two weeks after starting treatment in duration of 4 weeks for the whole treatment . The outcome measures will be evaluated before the commencements of conservative treatment, after the end of treatment , 4 weeks, 8 weeks and 12 weeks after end of treatment. Conservative therapy treatment is reversible and non invasive and provides self-care management in an environment to create patient responsibility for their own health. The patient will be informed that he has a problem with his jaw joint, to help himself, patient should try to understand some facts about temporomandibular disorder and try to follow the following instructions every day until his follow-up visit, then he will be assessed again and may be given further instructions. 1) This is a condition of your jaws and chewing muscles. It is often painful and may be accompanied by sound coming from your jaw joints as you talk, eat of yawn. This condition is not life-threatening but it can be uncomfortable and may interfere with your daily activities. There are many factors that contribute towards temporomandibular disorder and among them are psychological stresses. 2) Try to prevent aggravation of your temporomandibular disorder by resting your jaw muscles and joints. Avoid clenching and grinding your teeth. Try to constantly remind yourself to relax your jaw i.e. having your teeth apart and muscles relaxed. Avoid chewy or hard foods. Avoid biting your nails or on hard objects. Avoid eating on the side that hurts when you chew. 3) Try not to open your mouth too wide. Even when you are yawning try to remind yourself to minimize the width of mouth opening. Cut your food into smaller bite sizes. If you visit a dentist, inform him/her of your condition and take frequent breaks during the dental appointments. 4) Jaw exercises (passive and resistance jaw exercises) as is shown by the dentist treating your temporomandibular disorder condition, should be carried out in front of the mirror, three times a day, ten minutes each time. Note: the attending dentist must make sure that the patient has understood the instructions and has demonstrated it back for confirmation before the patient leaves the dental clinic. 5) Apply hot pack/compress onto the painful area of your jaws for about 20 minutes each time, three times a day. Make sure the temperature does not injure your skin. 6) Try to reduce any stresses to your body by practicing relaxation techniques. When you are stressed, you may tend to clench your jaws or grind your teeth at night or daytime. It also tightens up your face and neck muscles. Patient adherence to the treatment program will be tracked based on attendance to the scheduled sessions for follow up , it will be included a control card (check list) on which patients will list the techniques and exercises practiced at home with dates and times and handed over on each return. Failure to attend training sessions or failure to perform the exercises at home will lead to patient exclusion from the study. arm 3: combined treatment of low level laser therapy and home based exercises therapy following same previous protocols, patients will start home based exercise therapy for 4 weeks as in arm 2 protocol, during the last 10 days of the 4 weeks patient will receive laser sessions as in arm 1 protocol. The outcome measures will be evaluated before the commencements of combined treatment, after the end of treatment , 4 weeks, 8 weeks and 12 weeks after end of treatment. Patient adherence to the home based treatment program will be tracked based on attendance to the scheduled follow up sessions , it will be included a control card (check list) on which patients will list the techniques and exercises practiced at home with dates and times. Failure to attend sessions or failure to perform the exercises at home will lead to patient exclusion from the study.

Sponsors

Abdalwhab M Zwiri
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients aged 18 years and older. 2. Patient with TMD. 3. Good general state of health .

Exclusion criteria

1. Patients with trauma, craniofacial pathology, and previous TMJ surgeries. 2. Patients treated previously by low level laser therapy. 3. Patients complaining from migraine. 4. Patients with any systemic diseases like diabetes mellitus or osteoarthritis. 5. Patients taking long term steroids. 6. Patients taking antibiotics within last 2 weeks. 7. Patients taking immunosuppressant drugs and aspirin. 8. Pregnant and lactating women 9. Patients wearing any removable dental prosthesis or removable orthodontic appliances.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026