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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05951361
Enrollment
44
Registered
2023-07-19
Start date
2022-02-01
Completion date
2023-04-10
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Oral Lichen Planus

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.

Interventions

DEVICE980nm Diode Laser

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

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

the patients were randomly assigned to avoid bios.

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change of pain from the base line to 12 weeks follow-upbase line, 6weeks and 12 weeksVas is one way to express pain into a numerical value where 0 means no pain and 10 means worst pain ever

Secondary

MeasureTime frameDescription
change of clinical score of the lesion from the base line to 12 weeks follow-upbase line, 6weeks and 12 weeksThe 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

MeasureTime frameDescription
change in lipid peroxidation marker malondialdehyde from the base line to 12 weeks follow-up o 10 points VASbase line, 6weeks and 12 weeksmalondialdehyde is a strong marker for lipid peroxidation that can be measured in saliva to assess the effect of the treatment in oral lichen planus

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026