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Evaluation of the effect of probiotic lozenges in the treatment of recurrent aphthous stomatitis: a randomized, controlled clinical trial

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The study aimed to explore the effectiveness of probiotics in the treatment of minor recurrent aphthous stomatitis (RAS).

Materials and methods

We performed a randomized, controlled clinical study. Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups; AI and BI (test subgroups) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for 5 days. The size and pain level of ulcers were recorded on treatment days 0, 3, and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.


Compared with baseline, an improvement was evident for all subgroups. However, for effectiveness in pain reduction, a statistically significant difference in favor of AI was observed for all evaluation periods when compared with control subgroup. Regarding effectiveness in ulcer size reduction, a statistically significant difference in favor of BI was observed at day 5 when compared with control subgroup. No significant difference was observed in the effectiveness index between subgroups AI and BI (test subgroups) except in effectiveness in pain reduction at day 3. The outbreak frequency decreased significantly in subgroup BI.


Topical application of probiotics decreased pain intensity and accelerates RAS healing. The effectiveness in pain reduction is more evident in adult patients while acceleration of healing is more evident in children.

Clinical relevance

Probiotics could be a well-tolerated, topical therapeutic agent in the treatment of minor RAS.

Trial registration ID: NCT04383236

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All authors had substantial contributions for conception, design, analysis, interpretation of data, the drafting of the manuscript and critical revision for its intellectual content.

Corresponding author

Correspondence to Reham Lotfy Aggour.

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Conflict of interest

The authors declare that they have no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The clinical trial was approved from October 6 University, Faculty of Dentistry research ethics committee ((IEC)/23-2016) and registered in (ID: NCT04383236).

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Informed consent was obtained from all individual participants included in the study.

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Aggour, R.L., Mahmoud, S.H. & Abdelwhab, A. Evaluation of the effect of probiotic lozenges in the treatment of recurrent aphthous stomatitis: a randomized, controlled clinical trial. Clin Oral Invest 25, 2151–2158 (2021).

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