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

Not Applicable

Completed

• Conditions: Erosive Oral Lichen Planus
• Interventions: Device: 980nm Diode Laser; Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"

• Registration Number: NCT05951361
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2023-02-10
• Study Completion: 2023-04-10
• Status Verified: 2023-06
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-16
• Last Update Submitted: 2023-07-16
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
980nm Diode Laser	980nm Diode Laser	the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions
Kenacourt-A Orabase	0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"	the patients in this group received steroid therapy" Kenacourt-A Orabase" three times daily for 4 weeks. antifungal drug "miconazole oral gel" once daily for 1 week

Primary Outcome Measures

Name	Time	Method
change of pain from the base line to 12 weeks follow-up	base line, 6weeks and 12 weeks	Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever

Secondary Outcome Measures

Name	Time	Method
change of clinical score of the lesion from the base line to 12 weeks follow-up	base line, 6weeks and 12 weeks	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology; 🇪🇬 Alexandria, Al Iskandariyah, Egypt