None listed
Conditions
Brief summary
Oral lichen planus (OLP) is a chronic mucocutaneous disease, usually associated with pain and burning sensation, which can significantly alter quality of life. Until now, topical steroids have been considered the mainstay of OLP. However, the prolonged use of topical steroids could have several side effects and many patients could be refractory to steroids. Therefore, finding new effective and safe treatment modalities is fundamental. The purpose of the present study is to compare clinical efficacy and recurrence rates between CO2 vaporization and intralesional triamcinolone injections in the management of OLP. This study hypothesizes that CO2 laser vaporization is more effective in managing OLP than local steroid injections.
Interventions
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
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.
Sponsors
Damascus University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with bilateral, symptomatic oral lichen planus which are clinically and histologically confirmed.
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.
Outcome results
None listed