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Trial registered on ANZCTR


Registration number
ACTRN12622001424796
Ethics application status
Approved
Date submitted
7/10/2022
Date registered
8/11/2022
Date last updated
8/11/2022
Date data sharing statement initially provided
8/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of two treatment modalities for managing oral lichen planus.
Scientific title
CO2 Laser Evaporation versus Intralesional Triamcinolone Acetonide Injection in the Management of Oral Lichen Planus: A Randomized Controlled Trial with Split-Mouth Design.
Secondary ID [1] 308126 0
Nil known
Universal Trial Number (UTN)
U1111-1283-6505
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lichen planus 327843 0
Condition category
Condition code
Oral and Gastrointestinal 324919 324919 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
The intervention side will be treated with CO2 laser vaporization. After administration of local anesthesia, the entire lesion with 3 mm of the adjacent normal mucosa will be vaporized by moving the laser beam along the lesion in side-by-side strokes to a depth of approximately 1-2 mm using surgical CO2 laser (type CL15, Sunny Optoelectronic, Shanghai, China, wavelength= 10,600 nm). A continuous defocused mode with output power of 3W will be used for vaporization, and the speed movement will be 3mm\sec. The duration to complete the vaporization will depend on the lesion area, approximately (30-180) sec. A month after vaporizing the lesion on the intervention side, intralesional injections of triamcinolone acetonide (TA) (40 mg\ml; Triamcort, Ibn Hian, Homs, Syria) will be administered to the opposite side (control side). The injections will be placed directly into the subepithelial connective tissue using a 29-gauge insulin syringe. The injection points will be 1 cm apart. Thus, the total number of injections will depend on the area of each lesion. On average, (6±4) injection points will be needed. Each point will be injected with 0.1 ml (4 mg). The injection will be performed once a week for 4 weeks. The duration to complete the injection procedure will range between 30 and 120 sec, according to the lesion area. Both treatments will be administered by the same operator, who is an oral medicine specialist.
The lesions will be evaluated at baseline, one month after vaporizing the lesions on the intervention side to allow complete wound healing, and one week after the last injection session, which means at weeks o, 4 and 9. All patients will receive a follow-up for 9 months after the end of treatment to evaluate recurrence. Sessions attendance checklist will be used to monitor adherence to the intervention.
Intervention code [1] 324584 0
Treatment: Surgery
Intervention code [2] 324744 0
Treatment: Drugs
Comparator / control treatment
Triamcinolone Acetonide intralesional injection
Control group
Active

Outcomes
Primary outcome [1] 332732 0
Change in symptoms of oral lichen planus will be done using visual Analogue scale (VAS)
Timepoint [1] 332732 0
T0: at baseline
T1: 4 weeks post-commencement of intervention
T2: 9weeks post-commencement of intervention
Primary outcome [2] 332957 0
Change in signs of oral lichen planus will be measured using reticular-erythematous-ulcerative (REU) score
Timepoint [2] 332957 0
T0: at baseline
T1: 4 weeks post-commencement of intervention
T2: 9 weeks post-commencement of intervention
Primary outcome [3] 332958 0
Change in signs of oral lichen planus will be measled using thongprasom sign score (TSS)
Timepoint [3] 332958 0
T0: at baseline
T1: 4 weeks post-commencement of intervention
T2: 9 weeks post-commencement of intervention
Secondary outcome [1] 414535 0
Recurrence rate, which will be assessed clinically to detect any exacerbation in the primary outcomes (VAS, REU, TSS and lesion area)
Timepoint [1] 414535 0
9 months after the end of treatment
Secondary outcome [2] 415330 0
Change in the area of lesion (an additionally primary outcome)
The lesion area will be calculated in cm² by multiplying the greatest length and width of the lesion, which will be measured using a sterile flexible surgical ruler.
Timepoint [2] 415330 0
T0: at baseline
T1: 4 weeks post-commencement of intervention
T2: 9 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Patients with bilateral, symptomatic oral lichen planus which are clinically and histologically confirmed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of dysplasia on histological examination, the presence of co-occurring skin and/or genital lesions, receiving topical treatment for oral lichen planus (OLP) in the past 4 weeks, a history of steroids allergy, pregnant or lactating women, lichen-like lesions (systematic use of drugs that can cause lichenoid reactions, graft versus host disease), consumption of systematic drugs that may interfere with the treatment (steroids, immunosuppressive drugs, retinoids) during the past 6 months, and patients with uncontrolled systematic disease.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will be according to the lesions' side (Right or left side of the oral mucosa): lesions on the left side will receive CO2 laser treatment (intervention group), while lesions on the right side will receive TA injection (control group). All participants will undergo CO2 laser treatment first and then TA injection afterwards. The decision regarding the type of treatment provided to each side (either the left or right side of the oral mucosa) was made after tossing a coin.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated based on data from Mozafari et al. study, using the G * power 3.1.3 program, with a two-sided significance of 0.05 and a power of 0.95. The sample size was 14 lesions in each group. Taking into consideration sample attrition, two additional lesions will be added to each group. As a consequence, a total of 16 patients with bilateral OLP (32 affected sides) will be enrolled in the study.
Statistical analyses will be performed using the statistical software SPSS for Windows (version 25.0, SPSS Inc.,Chicago,IL,USA)

- The normality of distribution of the date will be verified by Shapiro-Wilk normality test.
- If the data were normally distributed, paired t-test will be applied.
- If the data were not normally distributed, Wilcoxon test will be applied.
-To compare the recurrence rates between the two groups the McNemar’s test will be used.
- The level of significance will be set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2019
Date of last participant enrolment
Anticipated
Actual
10/10/2021
Date of last data collection
Anticipated
Actual
12/07/2022
Sample size
Target
16
Accrual to date
Final
16
Recruitment outside Australia
Country [1] 25046 0
Syrian Arab Republic
State/province [1] 25046 0
Damascus

Funding & Sponsors
Funding source category [1] 312383 0
University
Name [1] 312383 0
Damascus University
Country [1] 312383 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] 313956 0
None
Name [1] 313956 0
None
Address [1] 313956 0
None
Country [1] 313956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311740 0
Ethical and Scientific Committee of dental research
Ethics committee address [1] 311740 0
Ethics committee country [1] 311740 0
Syrian Arab Republic
Date submitted for ethics approval [1] 311740 0
Approval date [1] 311740 0
26/05/2019
Ethics approval number [1] 311740 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122202 0
Dr Rengin Ibrahim
Address 122202 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122202 0
Syrian Arab Republic
Phone 122202 0
+963990244957
Fax 122202 0
Email 122202 0
rengin.ibrahim@damascusuniversity.edu.sy
Contact person for public queries
Name 122203 0
Rengin Ibrahim
Address 122203 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122203 0
Syrian Arab Republic
Phone 122203 0
+963990244957
Fax 122203 0
Email 122203 0
rengin.ibrahim@damascusuniversity.edu.sy
Contact person for scientific queries
Name 122204 0
Rengin Ibrahim
Address 122204 0
Faculty of Dental Medicine, Damascus University, Al-Mazzeh St.
Damascus, PO Box 30621
Country 122204 0
Syrian Arab Republic
Phone 122204 0
+963990244957
Fax 122204 0
Email 122204 0
rengin.ibrahim@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.