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Trial registered on ANZCTR


Registration number
ACTRN12620000442909
Ethics application status
Approved
Date submitted
19/01/2020
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical study on the effects of treating temporomandibular disorder (TMD) by low level laser therapy (LLLT), conservative and combination treatments
Scientific title
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.
Secondary ID [1] 300300 0
nill known
Universal Trial Number (UTN)
U1111-1246-8975
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Temporomandibular disorders ( TMD) 315899 0
Condition category
Condition code
Musculoskeletal 314168 314168 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 314169 314169 0 0
Physiotherapy
Inflammatory and Immune System 314170 314170 0 0
Rheumatoid arthritis
Oral and Gastrointestinal 314171 314171 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 316574 0
Treatment: Devices
Intervention code [2] 316575 0
Rehabilitation
Intervention code [3] 316576 0
Lifestyle
Comparator / control treatment
conservative treatment group ( home based exercise therapy)
Control group
Active

Outcomes
Primary outcome [1] 322551 0
Change in pain intensity ,measured by visual analog scale( VAS) graded from zero (no pain ) to 10 (maximum) pain
Timepoint [1] 322551 0
pain intensity will be evaluated before starting treatment(base line) , at last day of treatment ,
weeks 4 , 8 (primary endpoint), and 12 after end of treatment.
Primary outcome [2] 322552 0
Change in vertical range of movement of mandible in millimeter as in Research Diagnostic Criteria Axis 1 (examination form )
Timepoint [2] 322552 0
vertical range of movement of mandible will be evaluated before starting treatment (base line) , at last day of treatment , weeks 4 , 8(primary endpoint) and 12 from last day of treatment.
Primary outcome [3] 322553 0
change in temporomandibular joint sounds on palpation for vertical movements, as in Research Diagnostic Criteria Axis 1
Timepoint [3] 322553 0
change in temporomandibular joint sounds on palpation for vertical movements ,will be evaluated before starting treatment( base line) , at last day of treatment , weeks 4 , 8 (primary end point) and 12 from last day of treatment..
Secondary outcome [1] 378920 0
change in blood bio-marker interleukin 6 (IL-6) ( primary outcome)
Timepoint [1] 378920 0
blood bio-marker interleukin 6 (IL-6) will be assessed by measuring its level at the baseline and the end of the treatment
i.e before starting treatment and at the last day of treatment..
Secondary outcome [2] 378921 0
psycho social aspects, of temporomandibular disorder using RDC axis II
Timepoint [2] 378921 0
will be assessed by measuring changes between the baseline and 12 weeks after end of treatment
Secondary outcome [3] 378922 0
anxiety symptoms of temporomandibular disorder using Beck anxiety scale
Timepoint [3] 378922 0
Anxiety symptoms will be assessed by measuring changes between the baseline and 12 weeks after end of treatment
Secondary outcome [4] 380573 0
Change in lateral range of movement of the mandible in millimeter as in research diagnostic criteria for temporomandibular disorder RDC axis 1 (primary outcome)
Timepoint [4] 380573 0
Range of lateral movement of mandible will be evaluated before starting treatment (base line ) , at last day of treatment , weeks 4 , 8 (primary end point) and 12 from last day of treatment
Secondary outcome [5] 380574 0
Change in blood bio-marker interleukin 8 (IL-8) ( primary outcome)
Timepoint [5] 380574 0
Blood bio-marker interleukin 8 (IL-8) will be assessed by measuring its level at the baseline and the end of the treatment
i.e before starting treatment and at the last day of treatment.
Secondary outcome [6] 380575 0
change in blood bio-marker, high sensitivity C- reactive protein hs CRP. ( primary outcome)
Timepoint [6] 380575 0
Blood bio-marker, high sensitivity C- reactive protein hs CRP will be assessed by measuring its level at the baseline and the end of the treatment.
i.e before starting treatment and at the last day of treatment.
Secondary outcome [7] 380576 0
Change of jaw disability according to research diagnostic criteria RDC axis II
Timepoint [7] 380576 0
Jaw disability will be assessed by analysis of changes between the baseline and 12 weeks after end of treatment

Eligibility
Key inclusion criteria
1. Patients aged 18 years and older.
2. Patient with TMD.
3. Good general state of health .
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researcher will randomly assign the eligible patients into the treatments groups using block randomization of three blocks (ABC and CAB) where A refers to group I , B refer to group II, and C refer to group III so as to ensure equal number of patients in each group (10 patients per group). Initially, a rule for allocation will be set as even number will indicate ABC and odd number will indicate CAB. Then Microsoft excel software will be used to generate a random numbers from 1 to 14 and the blocks will be assigned to each number accordingly .for example all even numbers will be allocated ABC and all odd numbers will be allocated CAB. The generated blocks will be copied and each alphabet of the block will be written down and sealed separately in an envelope according to their sequence. When the first patient comes, the first envelop will be opened to identify the alphabet and the patient will then be allocated to one of the treatment groups accordingly. The same procedure will be applied for all patients. The people analyzing the results/data will be blinded regarding the treatment that the patient actually received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft excel software will be used to generate a random numbers from 1 to 14 and the blocks will be assigned to each number accordingly .for example all even numbers will be allocated ABC and all odd numbers will be allocated CAB. The generated blocks will be copied and each alphabet of the block will be written down and sealed separately in an envelope according to their sequence. When the first patient comes, the first envelop will be opened to identify the alphabet and the patient will then be allocated to one of the treatment groups accordingly. The same procedure will be applied for all patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation
Sample size calculation was done using PS software (Dupont and Plummer, 1997)by based on analysis of pain variability (Visual Analogue Scale–VAS), as published by Carrasco et al.,(2008) with a VAS standard deviation (SD) of 1.64 cm. A difference of 2.5 cm, 80% power, and 5% level of significance were used. we will need to study 8 experimental subjects in each study group, considering dropout 25%, some additional individuals will be recruited in each group.
Expected Results and statistical analysis
Documentation and evaluation of the data will be performed using a data processing program, SPSS/PC Version 24 for Windows (SPSS Inc., Chicago, IL, USA). Categorical variables at the baseline such as gender will be presented as frequencies and percentages, and will be analysed using Chi square/Fisher exact test. Age and VAS and all other numerical variables at the baseline will be analysed using one-way ANOVA. Two-way Anova will be used to analyse the between group effect (treatment groups), the within group effect (pre and post) and the interaction effect. The level of statistical significance will be set at P < 0.05.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22237 0
Malaysia
State/province [1] 22237 0
kelantan

Funding & Sponsors
Funding source category [1] 304722 0
University
Name [1] 304722 0
Universiti Sains Malaysia (USM). School of Dental Sciences Health Campus
Address [1] 304722 0
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country [1] 304722 0
Malaysia
Primary sponsor type
Individual
Name
Abdalwhab M Zwiri
Address
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country
Malaysia
Secondary sponsor category [1] 305037 0
University
Name [1] 305037 0
Universiti Sains Malaysia (USM). School of Dental Sciences Health Campus
Address [1] 305037 0
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country [1] 305037 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305148 0
JEPeM-USM
Ethics committee address [1] 305148 0
, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Ethics committee country [1] 305148 0
Malaysia
Date submitted for ethics approval [1] 305148 0
21/01/2019
Approval date [1] 305148 0
23/05/2019
Ethics approval number [1] 305148 0
USM/JEPeM/19010088

Summary
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.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99398 0
Dr Abdalwhab M A Zwiri
Address 99398 0
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country 99398 0
Malaysia
Phone 99398 0
+60102048190
Fax 99398 0
Email 99398 0
abdalwhab@student.usm.my
Contact person for public queries
Name 99399 0
Dr Abdalwhab M A Zwiri
Address 99399 0
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country 99399 0
Malaysia
Phone 99399 0
+60102048190
Fax 99399 0
Email 99399 0
dr_zwiri@yahoo.com
Contact person for scientific queries
Name 99400 0
Dr Abdalwhab M A Zwiri
Address 99400 0
School of Dental Sciences, Universiti Sains Malaysia,16150, Kota Bharu, Kubang Kerian, Kelantan, Malaysia
Country 99400 0
Malaysia
Phone 99400 0
+60102048190
Fax 99400 0
Email 99400 0
abdalwhab@student.usm.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All medical and dental information will be kept confidential by the study doctor and staff; and will not be made publicly available unless disclosure is required by law. Data that will be obtained from this study will not reveal the subject’s identity. Data will be secured in a password protected hard drive which will be accessible to researchers on research purposes only. The results of this study will be presented or published for the purpose of knowledge sharing.
What supporting documents are/will be available?
No other documents available
Summary results
No Results