JMIR Publications

ABSTRACT

Background:

Oral cancer is one of the most common cancers in India. It is usually preceded by Oral potentially malignant disorders like Oral leucoplakia (OL) in nearly two thirds of the cases. OL has high prevalence and malignant transformation rates (1.1% - 40.8%). There are no universal protocols for management in OL ranging from preventive, conservative, medical and surgical interventions. They have limitations and high recurrence rates requiring regular follow up. Removal of pathological lesions are believed to reduce the risk of malignant transformation in OL. Surgical methods have high morbidity and recurrence rates. Non –invasive methods like Photodynamic therapy (PDT) and topical Calcipotriol need to be explored. They would be preferred as they are cheaper, convenient, safe with better patient acceptability. They have the advantage of repeatability with minimum morbidity and damage to adjacent normal tissues.

Objective:

The primary objective is to compare the effect of 2.5% Toluidine blue mediated topical PDT and topical Calcipotriol (0.005%) on clinical response after completion of treatment at 4 weeks from baseline during management of OL. Secondary objectives are to assess lesion thickness, size, impact on oral health, salivary biomarkers, adverse events and recurrence.

Methods:

An open label prospective, single- centre, randomized clinical trial where Group A (n=83) will receive 4 sessions of Toluidine blue mediated photodynamic therapy (Fluence 15J/cm2) and Group B (n=83) will receive twice daily topical application of Calcipotriol (0.005%) over a period of 4 weeks as an adjunct to Conventional usual preventive care. The clinical response (complete/ partial/ none), lesion thickness/ whiteness, lesion size /area, Oral Health Impact Profile-14 scores, adverse events and recurrence rates will be compared with baseline at 4 weeks and 12 weeks after completion of therapy. Sterile PVA ophthalmic sponges will be used to evaluate salivary molecular markers ( IL6, TNF-α, PCNA, Survivin VEGF) from treatment site of lesion at baseline and 4 weeks after completion of treatment by ELISA. The data will be analysed statistically using Intention to treat and as per protocol analysis at significance levels of p<0.05.

Results:

This study has been approved by Institute Ethics Committee at all India Institute of Medical sciences New Delhi ( AIIMSA5773/13.02.2026, RP-29/2026)). Subject recruitment with follow up is expected to be completed by February 2027. Data analysis, manuscript preparation and submission for publication are expected to be completed May 2027.

Conclusions:

This novel RCT will generate evidence whether topical Toluidine blue mediated PDT or topical Calcipotriol is effective in improving clinical response, lesion thickness/ whiteness, lesion size and oral health quality of life in OL. Adverse events if any and recurrence rates or malignant transformation will also help in assessment of safety of the protocol. The molecular markers will help to monitor and determine prognosis of the lesions following treatment. Clinical Trial: ClinicalTrials.gov PRS_ PDT CACI NCT07453472