Back to resultsEvaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
Primary Purpose
Erosive Oral Lichen Planus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
980nm Diode Laser
0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Oral Lichen Planus
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
Sites / Locations
- Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Kenacourt-A Orabase
980nm Diode Laser
Arm Description
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
the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05951361
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
April 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Oral Lichen Planus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
the patients were randomly assigned to avoid bios.
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kenacourt-A Orabase
Arm Type
Active Comparator
Arm Description
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
Arm Title
980nm Diode Laser
Arm Type
Active Comparator
Arm Description
the patients received 980 nm diode laser treatment 300 mW, non-contact mode up to 10 sessions
Intervention Type
Device
Intervention Name(s)
980nm Diode Laser
Intervention Description
300 mW, 4 J/cm2, 2mm non-contact mode up to 10 sessions
Intervention Type
Drug
Intervention Name(s)
0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase"
Other Intervention Name(s)
Kenacourt-A Orabase
Intervention Description
three times daily for 4 weeks
Primary Outcome Measure Information:
Title
change of pain from the base line to 12 weeks follow-up
Description
Vas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever
Time Frame
base line, 6weeks and 12 weeks
Secondary Outcome Measure Information:
Title
change of clinical score of the lesion from the base line to 12 weeks follow-up
Description
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.
Time Frame
base line, 6weeks and 12 weeks
Other Pre-specified Outcome Measures:
Title
change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VAS
Description
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
Time Frame
base line, 6weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naguiba Mahmoud, Prof
Organizational Affiliation
department of oral medicine, faculty of dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Department of Oral Medicine, Periodontology, Oral Diagnosis and Oral Radiology
City
Alexandria
State/Province
Al Iskandariyah
ZIP/Postal Code
21648
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23549680
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.
Results Reference
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PubMed Identifier
24887747
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.
Results Reference
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Learn more about this trial
Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus
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