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Background <p>Topical application of 0.02% Mitomycin-C (MMC) has demonstrated efficacy in reducing fibrosis in ophthalmic and laryngeal procedures. This pilot study aimed to evaluate the potential role of MMC in enhancing healing outcomes in patients with Oral Submucous Fibrosis (OSMF) following surgical release of fibrous bands and reconstruction with the Buccal Fat Pad (BFP).</p> Methodology <p>A prospective, double-blinded, split-mouth feasibility pilot study was conducted on 10 patients diagnosed with OSMF. Each patient underwent surgical release of fibrous bands and/or coronoidectomy under general anaesthesia, followed by BFP reconstruction bilaterally. The right buccal mucosa (study side) received topical application of 0.02% MMC (0.2&#xa0;mg/ml) twice, first, for 5&#xa0;min over the raw surgical site before BFP placement, and again after 10&#xa0;days for 3&#xa0;min over the healing mucosa. The left side (control) received a placebo (normal saline) following the same protocol. Patients were assessed over three months for mucosal pliability, cheek flexibility, mucosal colouration and mouth opening.</p> Results <p>However, despite the theoretical antifibrotic potential of MMC, no statistically significant difference was observed between the MMC-treated and control sides with respect to mucosal pliability or cheek flexibility at any postoperative interval. Although preoperative cheek flexibility (4 ± 0.67&#xa0;mm) demonstrated initial postoperative improvement, this was not sustained during follow-up, and the MMC application did not confer any measurable long-term advantage over placebo. Additionally, mucosal coloration remained stable and comparable on both sides, indicating no clinically discernible enhancement in mucosal healing attributable to MMC. Notably, no adverse tissue reactions or complications were associated with MMC use, supporting its local biocompatibility. Postoperative mouth opening showed significant improvement from a baseline of 16 ± 2.79&#xa0;mm to 38.4 ± 1.58&#xa0;mm at 1&#xa0;week (T1), 36.1 ± 1.85&#xa0;mm at 1&#xa0;month (T2), and 33 ± 2.11&#xa0;mm at 3&#xa0;months (T3).</p> Conclusion <p>These findings suggest that while MMC is safe for intraoral application at this concentration, its therapeutic efficacy in mitigating fibrosis in the OSMF surgical site remains inconclusive, warranting further investigation through larger, controlled trials.</p> Trial registration <p>Clinical Trials Registry- India registration (CTRI/2022/04/041738) dated 08/04/2022).</p>

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Topical 0.02% mitomycin in postoperative healing of oral submucous fibrosis treated with fibrous band release and buccal fat pad reconstruction: a pilot split-mouth study

  • 期刊论文

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  • 发表日期：

    2026年1月14日

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  • Ankita Chugh,
  • Amanjot Kaur,
  • Gigi PG,
  • Pravin Kumar

摘要

Background

Topical application of 0.02% Mitomycin-C (MMC) has demonstrated efficacy in reducing fibrosis in ophthalmic and laryngeal procedures. This pilot study aimed to evaluate the potential role of MMC in enhancing healing outcomes in patients with Oral Submucous Fibrosis (OSMF) following surgical release of fibrous bands and reconstruction with the Buccal Fat Pad (BFP).

Methodology

A prospective, double-blinded, split-mouth feasibility pilot study was conducted on 10 patients diagnosed with OSMF. Each patient underwent surgical release of fibrous bands and/or coronoidectomy under general anaesthesia, followed by BFP reconstruction bilaterally. The right buccal mucosa (study side) received topical application of 0.02% MMC (0.2 mg/ml) twice, first, for 5 min over the raw surgical site before BFP placement, and again after 10 days for 3 min over the healing mucosa. The left side (control) received a placebo (normal saline) following the same protocol. Patients were assessed over three months for mucosal pliability, cheek flexibility, mucosal colouration and mouth opening.

Results

However, despite the theoretical antifibrotic potential of MMC, no statistically significant difference was observed between the MMC-treated and control sides with respect to mucosal pliability or cheek flexibility at any postoperative interval. Although preoperative cheek flexibility (4 ± 0.67 mm) demonstrated initial postoperative improvement, this was not sustained during follow-up, and the MMC application did not confer any measurable long-term advantage over placebo. Additionally, mucosal coloration remained stable and comparable on both sides, indicating no clinically discernible enhancement in mucosal healing attributable to MMC. Notably, no adverse tissue reactions or complications were associated with MMC use, supporting its local biocompatibility. Postoperative mouth opening showed significant improvement from a baseline of 16 ± 2.79 mm to 38.4 ± 1.58 mm at 1 week (T1), 36.1 ± 1.85 mm at 1 month (T2), and 33 ± 2.11 mm at 3 months (T3).

Conclusion

These findings suggest that while MMC is safe for intraoral application at this concentration, its therapeutic efficacy in mitigating fibrosis in the OSMF surgical site remains inconclusive, warranting further investigation through larger, controlled trials.

Trial registration

Clinical Trials Registry- India registration (CTRI/2022/04/041738) dated 08/04/2022).