Management of Pain in Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 4

Summary: 
      Treating Oral Lichen Planus (OLP) is a big challenge for clinicians. Despite numerous
      existing remedies, to date no effective cure has been found, which is mainly attributed to
      the lack of understanding of the pathogenesis of the disease. The investigator's aim was
      comparing the effectiveness of topical steroids and diode laser in treating OLP patients.
      Twenty-four patients with OLP were allocated into two groups of twelve patients each. One
      group was treated with 970 nm diode laser applied twice weekly and the other group was
      treated with topical steroids applied four times per day. Patients were followed up for two
      months. Pain was recorded using the visual analog score (VAS) and the clinical signs and
      symptoms were recorded using the reticular, atrophic, erosive (RAE) sores. Pain and RAE
      records were taken before treatment, after treatment and after 2 months.
    

Detailed description: 
      24 patients (16 females , 8 males ) were recruited in this study from the Dental Clinic of
      the National Research Centre, Egypt, and the Ethical Committee approved the study protocol.
      All patients were informed about the treatment plan and they all submitted a written informed
      consent before enrolment, which was carried out in accordance with the declaration of
      Helsinki. Inclusion criteria included oral lesions clinically and histopathologically
      consistent with the modifications for the WHO 2003 criteria suggested by van der Meij and van
      der Waal.13 Patients were excluded from the study in case of indefinite diagnosis (such as
      lichenoid inflammation); or those suffering from any disease that may present with features
      similar to OLP (graft versus host disease or lupus erythematosus),if they received any
      medication for OLP treatment in the two months prior enrolment in the study, if they were
      pregnant or lactating women, or if histological diagnosis revealed lichenoid changes or any
      signs of dysplasia. 4,14

      Study design:

      Patients were randomly divided into two groups using a randomization software, where a
      blocked randomization was used to ascertain equal distribution of patients into each group
      (parallel-group study).15 One group (12 patients) was irradiated with diode laser and the
      other group was treated with topical steroids. In the laser group, normal protective measures
      were taken, where patients and personnel wore laser safety glasses . OLP lesions were
      irradiated with a 970-nm diode laser (SIRO Laser Advance class III b, SIRONA, Germany) with a
      2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a
      fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5
      cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy
      covering all the lesional and peri-lesional tissues until blanching of the area was
      observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy
      of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one
      minute rest in between to allow for tissue relaxation.

      Irradiation was done twice weekly (once every third day) for two months until the resolution
      of signs (meaning the resolution of all atrophic-erosive lesions, regardless of any
      persisting hyperkeratotic lesions) for a maximum of ten sessions.11 After each session,
      patients were advised to have a cold diet and use chlorhexidine oral gel postoperatively. The
      patients applied the gel twice a day to the lesion for one week.16 For the steroid group (12
      patients), 0.1 % topical triamcinolone acetonide preparation (Kenacourt-A Orabase Pomad, DEVA
      HOLDINGS A.S., Istanbul, Turkey) was used where the patients' were instructed to apply the
      gel 4 times daily, with no food or fluid taken one hour after application. Patients used the
      medication for 4 weeks , and if extension of treatment was required after that period ,
      patients were instructed to apply miconazole oral gel (JANSSEN-CILAG Pty Ltd 1-5 Khartoum
      Road North Ryde NSW 2113 Australia) four times a day for one week to protect from
      superimposed fungal infections.15 Scoring of the clinical signs was done according to the RAE
      (Reticular, Erosive, Atrophic ) scale of Thongprasom and co- workers.17 Total improvement of
      the clinical signs was given scores zero or one and was defined as the disappearance of all
      atrophic-erosive lesions, whether any hyperkeratotic lesions persisted or not. Partial
      improvement or persisting of the patient's condition meant a decrease (score 2, 3 or 4), or
      no improvement (no change in the patient's score). Hence the clinical and symptomatic
      improvement of the patient's lesion was expressed by the numerical difference between
      baseline and endpoint scores. 14 Pain was recorded using the Visual Analogue Scale (VAS),
      which consisted of a 10-cm horizontal line, starting from 0 (designating no pain experienced
      by the patient to 10 (designating unbearable or most severe pain). Pain and RAE records were
      taken before treatment, after treatment and then after 2 months follow up.
    

Intervention name(s): 0.1 % topical triamcinolone acetonide; SIROIaser
Intervention type(s): Drug; Device
Intervention description(s): 0.1 % topical triamcinolone acetonide preparation was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application.; Oral Lichen Planus lesions were irradiated with a 970-nm diode laser with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
Irradiation was done twice weekly (once every third day) for two months until the resolution of signs for a maximum of ten sessions.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care