Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus

Erosive Oral Lichen Planus Clinical Trial

Official title:

Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05951361
• Other study ID #: 0369-01/2022
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: June 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Oral Lichen Planus
• Lichen Planus
• Lichen Planus, Oral

Intervention

Device:
• 980nm Diode Laser
300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions

Drug:
• 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
three times daily for 4 weeks

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology	Alexandria	Al Iskandariyah

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS	malondialdehyde is a strong marker for lipid peroxidation that can be measured in saliva to assess the effect of the treatment in oral lichen planus	base line, 6weeks and 12 weeks
Primary	change of pain from the base line to 12 weeks follow-up	Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever	base line, 6weeks and 12 weeks
Secondary	change of clinical score of the lesion from the base line to 12 weeks follow-up	The size of the lesion is monitored where score 0 no lesions, score 1 : mild white striation only, score 2 : white striation with erythematous area < 1 cm 2, score 3 : white striation with erythematous area > 1 cm 2, score 4 : white striation < 1 cm2, score 5 : white striation with erosive area > 1 cm2.	base line, 6weeks and 12 weeks