Clinical trial NCT05951361: Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
Official title: Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erosive Oral Lichen Planus
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study evaluates the effect of diode laser in treatment of oral lichen planus.

Detailed description: 44 patients with erosive oral lichen planus were included in the study and divided into 2 equal groups. Group I received topical steroid therapy three times daily for 4 weeks and antifungal oral gel once daily for 1 week. Group II received 980nm Diode Laser 300 mW, up to 10 sessions.

Eligibility criteria: Inclusion Criteria:

* Patient histologically diagnosed with erosive OLP based on WHO modified criteria 2003.
* Presence of painful erosive OLP lesions diagnosed by biopsy

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients currently treated for cancer with Chemotherapy or Radiotherapy
* Patient currently on Corticosteroid therapy or had this treatment on the past 3 months
* Those who had used Anti-inflammatory drugs topical or systemic in the last month
* the use of drugs related to Oral Lichenoid Lesions
* Presence of Amalgam restorations near the OLP lesions
* dysplasia in histopathological examination
* uncontrolled systemic diseases
* physical or mental abnormality which would interfere with or be affected by the study procedure
* Patients with skin lesion

Primary outcomes:
measure: change of pain from the base line to 12 weeks follow-up
timeFrame: base line, 6weeks and 12 weeks
Secondary outcomes:
measure: change of clinical score of the lesion from the base line to 12 weeks follow-up
timeFrame: base line, 6weeks and 12 weeks
Other outcomes:
measure: change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS
timeFrame: base line, 6weeks and 12 weeks
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology
state: Al Iskandariyah
Study officials:
affiliation: department of oral medicine, faculty of dentistry
name: Naguiba Mahmoud, Prof
role: STUDY_DIRECTOR
References:
citation: Cafaro A, Arduino PG, Massolini G, Romagnoli E, Broccoletti R. Clinical evaluation of the efficiency of low-level laser therapy for oral lichen planus: a prospective case series. Lasers Med Sci. 2014 Jan;29(1):185-90. doi: 10.1007/s10103-013-1313-6. Epub 2013 Apr 3.
citation: Dillenburg CS, Martins MA, Munerato MC, Marques MM, Carrard VC, Sant'Ana Filho M, Castilho RM, Martins MD. Efficacy of laser phototherapy in comparison to topical clobetasol for the treatment of oral lichen planus: a randomized controlled trial. J Biomed Opt. 2014 Jun;19(6):068002. doi: 10.1117/1.JBO.19.6.068002.