Treatment Of Oral Lichen Planus

This clinical study aims to explore a novel alternative treatment for oral lichen planus (OLP) utilizing Daivobet ointment, a combination of calcipotriol and betamethasone. The protocol is designed to provide in-depth technical information on patient selection, treatment procedures, clinical assessments, and statistical analyses, ensuring a comprehensive understanding of the study's methodology.

Patient Selection:

Fifteen patients aged 30-60 with bilateral intra-oral erosive lichen planus symptoms will be recruited from the department of Oral Medicine and Diagnosis at the Faculty of Dentistry, Kafr Elsheikh University. Participants with a history of unresponsiveness to current therapies will undergo histopathological confirmation through incisional biopsy.

Inclusion Criteria:

Presence of bilateral oral erosive lichen planus lesions. Clinical and histopathological diagnosis of oral lichen planus based on a modified definition of the World Health Organization (WHO).

Exclusion Criteria:

Histological signs of dysplasia. Use of drugs possibly causing a lichenoid reaction and lesions in contact with dental amalgam restorations.

Any topical or systemic medications used in the treatment of oral lichen planus within four weeks before the study.

Patients with a history of hypersensitivity to the drug used in the current study.

Clinical Assessment:

Patients will be instructed to topically apply Daivobet ointment on one side and a topical steroid on the other side three times daily for four weeks. Clinical evaluations will be conducted at the study's onset, with baseline parameters recorded, and reassessed at the end of the second and fourth weeks.

Objective Response:

Lesions of oral lichen planus will be scored using a scaled tongue blade, categorizing them from 0 (no lesion) to 5 (erosive area >1cm2). Quantitative measurements will be calculated using a transparent grid to obtain the total area of the lesion.

Subjective Response:

Discomfort scores will be recorded on a visual analog scale ranging from 0 to 3, and a questionnaire documenting potential adverse effects will be completed. Patients will rank the severity of their discomfort.

Biopsy Specimens and Laboratory Investigations:

Incisional biopsy specimens will be obtained under local anesthesia, incorporating both clinically normal and diseased tissues. The specimens will undergo routine histologic study, confirming the diagnosis through formalin-fixed, paraffin-embedded, hematoxylin-and eosin-stained sections.

Statistical Analysis:

Data analysis will be performed using SPSS version 16 for Windows. The normality of data will be assessed using Shapiro-Wilk tests. Descriptive statistics, median, minimum, and maximum tests will be employed to describe the measure of central tendency and dispersion in each group. Groups will be compared using the Mann-Whitney U test. For non-parametric continuous variables, the degree of improvement will be calculated, and the mean value for the degree of improvement used to compare between groups. The significance level will be set at P ≤ 0.05.

Patient Registry Procedures:

Quality assurance plan addressing data validation, registry procedures, site monitoring, and auditing.

Data checks to compare entered data against predefined rules for range or consistency.

Source data verification assessing the accuracy, completeness, or representativeness of registry data by comparing it to external sources.

Data dictionary containing detailed descriptions of each variable, including source, coding information, and normal ranges.

Standard Operating Procedures covering registry operations and analysis activities, including patient recruitment, data collection, management, analysis, reporting for adverse events, and change management.

Sample size assessment specifying the number of participants or participant years necessary to demonstrate an effect.

Plan for missing data addressing situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing due to data inconsistency or out-of-range results.

Statistical analysis plan describing the analytical principles and techniques employed to address the primary and secondary objectives, as specified in the study protocol or plan.