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Outcome of a Novel Drug Combination in the Medical Management of Oral Submucous Fibrosis Patients: A Retrospective Cohort Study

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Abstract

Aim

To evaluate the efficacy of a new drug combination in the medical management of oral submucous fibrosis (OSMF) patients.

Materials and Methods

This retrospective cohort study included 89 patients who were clinically diagnosed of having OSMF (grade I, II, III). These patients had been administered the new drug combination for 6 months and clinical parameters such as burning sensation score, mouth opening and tongue protrusion were evaluated at 1 month, 3 months, 6 months and 12 months post-medication retrospectively.

Results

Out of the total 89 patients included in the study, 18 patients had Grade-I, 50 patients had Grade-II and 21 patients had Grade-III OSMF. A significant improvement was observed in the mouth opening and tongue protrusion in all the three grades of OSMF from baseline to 1 month, 3 months, 6 months and 12 months after treatment (p < 0.0001) on intra- and intergroup comparison. A significant reduction in the burning sensation score from baseline to 1 month, 3 months, 6 months and 12 months after treatment was observed (p < 0.0001) in all the three grades on intra group comparison.

Conclusion

This retrospective study showed that this novel drug combination is significantly effective in improving burning sensation score, mouth opening and tongue protrusion in OSMF grade I, II and III patients with results consistent after 1 year of follow-up.

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Funding

No funding was received for conducting this study by any organization.

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Authors and Affiliations

  1. Director, The Facial Surgery Hospital, Rajkot, Gujarat, India

    Kaushik H. Pethani

  2. The Facial Surgery Hospital, Rajkot, Gujarat, India

    Samruddhi J. Borate

Authors
  1. Kaushik H. Pethani
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  2. Samruddhi J. Borate
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Correspondence to Samruddhi J. Borate.

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Conflict of interests

CAPSULE SMF CARE® is a registered trademark of author 1 and the author holds proprietary interest with the same.

Ethical approval

Ethical approval was waived by the local Ethics Committee of “Institutional Ethics Committee Human, Gokul Lifecare Private Limited” in view of the retrospective nature of the study, and all the procedures being performed were part of the routine care.

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Pethani, K.H., Borate, S.J. Outcome of a Novel Drug Combination in the Medical Management of Oral Submucous Fibrosis Patients: A Retrospective Cohort Study. J. Maxillofac. Oral Surg. (2024). https://doi.org/10.1007/s12663-023-02096-y

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  • DOI: https://doi.org/10.1007/s12663-023-02096-y

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