An interventional study of 980nm Diode Laser and 0.1% topical triamcinolone Acetonide preparation "Kenacourt-A Orabase" in Erosive Oral Lichen Planus, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
this study evaluates the effect of diode laser in treatment of oral lichen planus.
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.
Alexandria University is the lead sponsor of 586 studies on the registry; 127 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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"
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
three times daily for 4 weeks
Also known as: Kenacourt-A Orabase
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
Time frame: base line, 6weeks and 12 weeks
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.
Time frame: base line, 6weeks and 12 weeks
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
Time frame: base line, 6weeks and 12 weeks
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Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
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.
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.
Ran from Feb 2022 to primary completion in Feb 2023, 12 months.
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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