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Comparative evaluation of the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel in oral lichen planus—a double-blinded randomized control trial

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Abstract

Objectives

The a im of this study is to evaluate and compare the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel for the management of oral lichen planus (OLP).

Study design

Sixty clinically diagnosed cases of OLP were stratified into moderate cases or severe cases based on burning sensation before getting allocated to group I receiving Nigella sativa cream and group II receiving clobetasol propionate gel, two times a day for 45 days. Patients were examined every 15 days for a change in burning sensation and size of the lesion using the numeric pain rating scale (NRS) and a standard Vernier caliper, respectively. Statistical tests including Mann–Whitney U, Wilcoxon signed-rank, Friedman’s, Dunn’s post hoc, unpaired t, paired t, one-way repeated measures ANOVA, and Bonferroni’s post hoc were applied.

Results

There was a statistically significant reduction in the burning sensation as well as the size of the lesion in both groups (P ≤ 0.05). There was an 87.8% (moderate cases) and 85.7% (severe cases) reduction in the mean NRS scores on the 45th day in group I when compared to the 96.5% (moderate cases) and 93.48% (severe cases) in group II. There was a 92.9% (moderate cases) and 90.7% (severe cases) reduction in the size of the lesion in group I when compared to the 92.6% (moderate cases) and 93.1% (severe cases) in group II.

Conclusion

The topical application of Nigella sativa cream was effective and comparable to clobetasol propionate 0.05% gel in the management of OLP, without any side effects. Hence, this study recommends the use of topical Nigella sativa cream therapy in the management of OLP.

Clinical relevance

The current mainstay of treatment for OLP is the administration of topical or systemic corticosteroids, which are known to cause side effects, demanding a search for an alternative. Nigella sativa oil cream could be a safe, promising, cost-effective, adjunctive, or alternative modality.

Clinical trial registration number: CTRI/2020/07/026745 (India).

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.

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Acknowledgements

We would like to acknowledge the support of Dr. UB Bolmal (Retd. Assistant Professor) and Mrs. Nisha S Shirkoli (Assistant Professor), KLE College of Pharmacy, Belagavi for the formulation of Nigella sativa cream. We would also like to thank Greenish Health Care Pvt. Ltd., Chennai and VDH Chem Tech Pvt. Ltd., Ghaziabad for providing the gift samples of Nigella sativa oil and butylated hydroxytoluene, respectively.

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Authors and Affiliations

  1. Department of Oral Medicine, Radiology, and Special Care Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences (SIMATS), No. 162, Poonamalle High Road, Chennai-, 600077, Tamil Nadu, India

    Lokesh Kumar S

  2. Department of Oral Medicine and Radiology, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education and Research, JNMC Campus, Nehru Nagar, Belagavi-, 590010, Karnataka, India

    Zameera Naik, Arun Panwar, Sridhar M & Vaishali Keluskar

  3. Department of Public Health Dentistry, KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, KLE Academy of Higher Education and Research, JNMC Campus, Nehru Nagar, Belagavi-, 590010, Karnataka, India

    Ram Surath Kumar

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Contributions

Dr. Lokesh Kumar S: conceptualization, data curation, formal analysis, investigation, methodology, project administration, and writing (original draft); Dr. Zameera Naik: conceptualization, data curation, supervision, validation, visualization, and writing (review and editing); Dr. Arun Panwar: writing (original draft); Dr. Sridhar M: writing (original draft); Dr. Vaishali Keluskar: supervision, validation, visualization, and writing (review and editing); Dr. Ram Surath Kumar K: formal analysis. All the authors reviewed the manuscript.

Corresponding author

Correspondence to Lokesh Kumar S.

Ethics declarations

Ethical approval and consent to participate

The authors declare that this randomized control trial was registered in the Clinical Trial Registry of India with ref. no: CTRI/2020/07/026745. Ethical clearance was obtained from the Institutional Research and Ethics Committee with ref. no: 1333, and the participants were asked to sign a written consent form prior to the start of the study.

Consent for publication

The authors and involved participants provide their consent to publish the data and findings of the study.

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The authors declare there are no competing interests.

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Kumar S, L., Naik, Z., Panwar, A. et al. Comparative evaluation of the efficacy of Nigella sativa (75% v/v) cream and clobetasol propionate (0.05% w/w) gel in oral lichen planus—a double-blinded randomized control trial. Oral Maxillofac Surg 28, 225–234 (2024). https://doi.org/10.1007/s10006-022-01130-6

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