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

July 16, 2023 updated by: Alexandria University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Iskandariyah
      • Alexandria, Al Iskandariyah, Egypt, 21648
        • Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
three times daily for 4 weeks
Other Names:
  • Kenacourt-A Orabase
Active Comparator: 980nm Diode Laser
the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions
Device: 980nm Diode Laser
300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
base line, 6weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
base line, 6weeks and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
base line, 6weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Director: Naguiba Mahmoud, Prof, department of oral medicine, faculty of dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 10, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0369-01/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to the data may be extended beyond the initial 24-month period upon request and approval, which will also be evaluated on a case-by-case basis.

IPD Sharing Time Frame

The submission of data requests can commence nine months after the article has been published, and the data will be available for up to 24 months. Extensions will be reviewed on a case-by-case basis.

IPD Sharing Access Criteria

Qualified researchers who are conducting independent scientific research may request access to trial IPD. Upon review and approval of a research proposal and Statistical Analysis Plan (SAP), and the execution of a Data Sharing Agreement (DSA), access will be granted. For additional information or to request access, please contact the data provider. Approval for the extension of access beyond the initial 24-month period will also be considered on a case-by-case basis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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