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NCT Number: NCT05951361

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

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

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Key information

Conditions

Erosive Oral Lichen Planus

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology

Alexandria, Alexandria Governorate, 21648, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

980nm Diode Laser

Device

300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions

0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"

Drug

three times daily for 4 weeks

Other names: Kenacourt-A Orabase

Primary outcomes

  1. change of pain from the base line to 12 weeks follow-up

    Time frame: 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 outcomes

  1. change of clinical score of the lesion from the base line to 12 weeks follow-up

    Time frame: 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.

Other outcomes

  1. change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS

    Time frame: base line, 6weeks and 12 weeks

    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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2023
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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