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Active Not Recruiting
NCT07658508
Topical Calcipotriol Versus Photodynamic Therapy in the Treatment of Oral Leukoplakia
Conditions: Oral Leukoplakia
Sex: All
Ages: 25 Years – 55 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 30
Sponsor: Alexandria University
Location: Faculty of Dentistry, Alexandria University Alexandria
Summary
The goal of this clinical trial is to learn if calcipotriol and photodynamic therapy are equally effective in treatment of leukoplakia or not. The main questions it aims to answer are:
do lesions decrease or disappear when treated by calcipotriol or PDT? does the drug affect the salivary biomarkers
Participants will:
Take calcipotriol daily for 4 weeks or perform 4 PDT sessions over 4 weeks measure changes in salivary biomarkers be followed up for 3 months
Eligibility Criteria
Inclusion Criteria:
* Patients, both males and females, 25 to 55years old will be included in this clinical trial.
* Patients with oral leukoplakia with histologically confirmed mild and moderate epithelial dysplasia.
* Patients willing and able to return for multiple follow up visits
Exclusion Criteria:
* Presence of any visible oral lesions other than leukoplakia.
* Periodontitis patients: since chronic periodontitis may affect salivary TNF-alpha and MMP-9 level.
* Contraindications for the use of calcipotriol or amino levulonic acid as allergy.
* History of topical and/or systemic therapy for 2 months before the start of study.
* Patients with conditions that could affect saliva collection as xerostomia.
Source: ClinicalTrials.gov (NCT07658508). StuddyBuddy aggregates publicly available trial information.