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Comparing the efficacy of a novel mucoadhesive patch containing Nigella sativa 10% with triamcinolone 0.1% in patients with erosive-atrophic oral lichen planus: A pilot study.

  • 2024-05-26
  • Clinical and experimental dental research 10(3)
    • Atessa Pakfetrat
    • Zahra Delavarian
    • Mahshid Malakooti
    • Hossein Bagheri
    • Habibollah Esmaily
    • Mahsa Ghorbani
    • Pooya Saeedi

Study Design

Type
Clinical Trial
Sample size
n = 10
Population
patients with erosive-atrophic oral lichen planus
Methods
pilot study comprising two groups, each with 10 patients; intervention group received mucoadhesive patches containing N. sativa 10% extract, control group received triamcinolone acetonide 0.1% patches; assessed weekly for 4 weeks
Duration
4 weeks

Objective

This study evaluates the efficacy of a novel mucoadhesive patch containing Nigella sativa 10% extract compared to triamcinolone 0.1% in alleviating symptoms and reducing lesion severity in patients with erosive-atrophic oral lichen planus.

Methods and materials

A pilot study comprising two groups, each with 10 patients, was conducted. The intervention group received mucoadhesive patches containing N. sativa 10% extract, while the control group received triamcinolone acetonide 0.1% patches. Pain and burning intensity, measured through visual analog scale, and lesion severity based on the Thongprasom scale were assessed weekly for 4 weeks. Descriptive records were kept for side effects and patient satisfaction.

Results

Pain and burning intensity decreased in both groups throughout the sessions, with the N. sativa group showing a greater reduction than the triamcinolone group. The reduction in burning intensity within each group was significant (p < .001), and there was a significant difference between groups only in the second session (p = .045). The overall difference between groups was not significant (p > .05). Lesion severity also decreased significantly in both groups (p < .001), with a significant difference between groups observed in the third session (p = .043) and overall throughout the study (p = .006).

Conclusion

The use of N. sativa extract in mucoadhesive patches was as effective as corticosteroids in reducing pain, burning, and lesion severity in patients with oral lichen planus, with N. sativa showing superior results in some sessions. Notably, no significant complications were observed with N. sativa use, making it a promising treatment option for lichen planus.

Research Insights

  • Black Cumin→Reduced Burning Intensity

    The overall difference between groups was not significant (p > .05).

    Effect
    Neutral
    Effect size
    Small
    Dose
    10% extract in mucoadhesive patch
  • Black Cumin→Reduced Lesion Severity

    Lesion severity also decreased significantly in both groups (p < .001), with a significant difference between groups observed in the third session (p = .043) and overall throughout the study (p = .006).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    10% extract in mucoadhesive patch
  • Black Cumin→Reduced Pain Intensity

    Pain and burning intensity decreased in both groups throughout the sessions, with the N. sativa group showing a greater reduction than the triamcinolone group. The reduction in burning intensity within each group was significant (p < .001).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    10% extract in mucoadhesive patch

Adverse Events Reported

  • Black Cumin→Overall tolerability

    Notably, no significant complications were observed with N. sativa use, making it a promising treatment option for lichen planus.

    Finding
    Reported
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