Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000132640
Ethics application status
Approved
Date submitted
18/01/2023
Date registered
8/02/2023
Date last updated
8/02/2023
Date data sharing statement initially provided
8/02/2023
Date results information initially provided
8/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Botulinum Toxin injection in different group of muscles for the management of TMJ myofacial pain.
Scientific title
Comparison of the efficacy of Botulinum Toxin injection in masseter muscles versus in the lateral pterygoid and temporalis muscles for the management of TMJ myofacial pain.
Secondary ID [1] 308164 0
Nil known
Universal Trial Number (UTN)
U1111-1283-7499
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myofascial Pain - Dysfunction Syndrome of TMJ 327884 0
Condition category
Condition code
Musculoskeletal 324970 324970 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment will be administered by the main researcher at the study clinic. Botulinum toxin type A (BTA) will be reconstituted with normal saline to 5 units/0.1 mL. BTA will be injected bilaterally into the lateral pterygoid and temporalis muscles.
Five units of BTA will be injected in each group of temporalis muscle fibers, the anterior, middle, and posterior fibers, in a total dose of 15 units per muscle. 10 Units of BTA will be injected intraorally in each lateral pterygoid muscle using pre-sterilized disposable injectable monopolar needle electrodes for EMG 37mm x 26ga (Chalgren Enterprises Inc, USA). The needle will be inserted at the mucobuccal fold of the distal root of the upper second molar. The angulation of the inserted needle will be posteriorly and superiorly by 30 degrees with the occlusal plane and 20 degrees medially. The depth of insertion will be between 20 to 30 mm. Before injection, the syringe will be aspirated to ensure the needle has not pierced a blood vessel. Using an electromyography appliance (Micromed, Italy), the correct electrode placement will be verified by evaluating the full recruitment of electromyographic signal during contralateral mandibular movement. In addition, 0.5 mL of normal saline will be injected into each masseter muscle as a placebo. Each participant will only need to attend 1 x 30 min session of treatment. A study team member will monitor adherence to the intervention using a checklist.
Intervention code [1] 324610 0
Treatment: Drugs
Comparator / control treatment
Twenty-five units of BTA will be injected bilaterally into masseter muscles. The injection will be carried out at five different points inside the safe zone described by Peng et al. 2017. The safe zone border is located 1 cm away from four lines. The upper line extends from the mouth corner to the earlobe. The inferior line keeps pace with the inferior edge of the mandible. The posterior and anterior lines resemble the anterior and posterior edges of the masseter muscle. In addition, 0.2 and 0.3 mL of normal saline will be injected into lateral pterygoid and temporalis muscles, respectively.
Control group
Active

Outcomes
Primary outcome [1] 333457 0
- Pain on palpation using visual analogue scale (VAS).
Timepoint [1] 333457 0
- Before injection
- After 2 weeks
- After 2 months
- After 4 months
- After 6 months (primary timepoint)
Primary outcome [2] 333458 0
-Maximal opening mouth without pain. This will be measured by asking the patient to open their mouth as wide as possible without pain and measuring the distance between the edges of the central incisors with a caliper.
Timepoint [2] 333458 0
- Before injection
- After 2 weeks
- After 2 months
- After 4 months
- After 6 months (primary timepoint)
Primary outcome [3] 333459 0
-Plaque on the buccal surfaces of molars and premolars using Turesky Modified Quigley-Hein (TMQH) plaque index.
Timepoint [3] 333459 0
- Before BTA injection into masseter muscle.
- After 2 weeks.
Secondary outcome [1] 417153 0
Molars and premolars buccal surfaces mineralization. which will be assessed using Diagnodent.
Timepoint [1] 417153 0
- Before BTA injection into masseter muscle
- After one month of the injection.
Secondary outcome [2] 417154 0
- Unstimulated salivary flow rates.
Timepoint [2] 417154 0
- Before BTA injection into masseter muscle.
- After 2 weeks.
Secondary outcome [3] 417155 0
- Investigate changes in mandibular angle volume using cone beam computed tomography (CBCT) which will be taken for each patient before BTA injection and after 6 months of the injection.
Timepoint [3] 417155 0
- Before BTA injection.
- After 6 months.
Secondary outcome [4] 417156 0
- Investigate Changes in condyle using CBCT.
Timepoint [4] 417156 0
- Before BTA injection.
- After 6 months.
Secondary outcome [5] 417515 0
- Investigate changes in masseter muscle thickness using CBCT.
Timepoint [5] 417515 0
- Before BTA injection.
- After 6 months

Eligibility
Key inclusion criteria
- Patients with myofacial pain according to RDC-TMD axis I.
-The pain intense on VAS is more than 5.
- Bruxism.
- Mild teeth wear include the centrals and canines.
- Limited mouth opening due to muscles spasm.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients known to be allergic to any botulinum toxin.
- Patients who underwent any botulinum toxin type A treatment in less than six months
- Pregnant or breastfeeding women.
- Patients addicted to narcotic drugs or alcohol.
- Patients with depression and/or somatization according to RDC-TMD axis II.
- People with neurological disorders.
- Patients taking aminoglycosides.
- Active infection at the injection site.

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)
Computer generated randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was done based on analysis of pain variability (Visual Analogue Scale–VAS) with a standard deviation (SD) of 2.19 as published in Hosgor et al.,(2020) study using G * power 3.1.3 software. A difference of 2.5, 80% power, and 5% level of significance were used. The sample needed is 11 subject in each group. Considering 20% dropout rate the total sample size was increased to 26 patient.
Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA)
- Shapiro-Wilk normality test will be used to determine the of distribution of the data.
- independent simple t-test will be applied between groups for the normally distributed data.
- Mann–Whitney U test will be applied between groups if the data were not normally distributed.
- paired simple t-test will be applied within each group for the normally distributed data.
- Wilcoxon test will be applied within each group if the data were not normally distributed.
- Repeated measures Anova for the normally distributed data.
- Friedman test if the data were not normally distributed.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
5/01/2021
Date of last participant enrolment
Anticipated
Actual
15/08/2022
Date of last data collection
Anticipated
15/02/2023
Actual
Sample size
Target
26
Accrual to date
Final
26
Recruitment outside Australia
Country [1] 25208 0
Syrian Arab Republic
State/province [1] 25208 0
Damascus

Funding & Sponsors
Funding source category [1] 312423 0
University
Name [1] 312423 0
Damascus University
Country [1] 312423 0
Syrian Arab Republic
Primary sponsor type
University
Name
Damascus University
Address
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St., Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 313995 0
None
Name [1] 313995 0
None
Address [1] 313995 0
None
Country [1] 313995 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311768 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 311768 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh Street, Damascus, Syria
Ethics committee country [1] 311768 0
Syrian Arab Republic
Date submitted for ethics approval [1] 311768 0
Approval date [1] 311768 0
01/09/2020
Ethics approval number [1] 311768 0

Summary
Brief summary
The primary purpose of this study is to compare the efficacy of Botulinum toxin type A (BTA) injection into masseter muscles alone versus injection of the same amount of BTA into lateral pterygoid and temporalis muscles for the management of patients with myofacial pain and bruxism. Mandibular movements during bruxism include open-close, lateral and anterior-posterior moves. These movements will be reduced when BTA is injected into lateral pterygoid and temporalis muscles. On the other hand, when BTA is injected into the masseter muscles, only the closing movement will be affected. Thus the main null hypothesis for this study is that there is no difference between the injection of BTA into masseter muscles or lateral pterygoid and temporalis muscles. We also aim to investigate the morphological changes in the condyle, mandibular angle, and masseter muscle volume using CBCT. Furthermore, the effect of BTA injection into masseter muscles on saliva, plaque formation, and teeth mineralization will be studied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122298 0
Dr Aladdin Alshawa
Address 122298 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122298 0
Syrian Arab Republic
Phone 122298 0
+963934587086
Fax 122298 0
Email 122298 0
aladdin.alshawa@damascusuniversity.edu.sy
Contact person for public queries
Name 122299 0
Dr Aladdin Alshawa
Address 122299 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122299 0
Syrian Arab Republic
Phone 122299 0
+963934587086
Fax 122299 0
Email 122299 0
aladdin.alshawa@damascusuniversity.edu.sy
Contact person for scientific queries
Name 122300 0
Dr Aladdin Alshawa
Address 122300 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122300 0
Syrian Arab Republic
Phone 122300 0
+963934587086
Fax 122300 0
Email 122300 0
aladdin.alshawa@damascusuniversity.edu.sy

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.