Efficacy and Safety of Dexamethasone Ointment on Recurrent Aphthous Ulceration

doi:10.1016/j.amjmed.2011.09.011

The American Journal of Medicine

Volume 125, Issue 3, March 2012, Pages 292-301

https://doi.org/10.1016/j.amjmed.2011.09.011 Get rights and content

Abstract

Objective

Recurrent aphthous ulceration is the most common oral mucosal lesion and may be associated with many systemic diseases. Topical corticosteroids are used frequently for recurrent aphthous ulceration; however, the number of high-quality clinical experiments available is insufficient, and no reports exist on the blood level of corticosteroids after topical usage in the oral mucosa. The objective was to determine the efficacy and safety of dexamethasone ointment in the treatment of recurrent aphthous ulceration and detect serum dexamethasone concentrations in the patients.

Methods

A randomized, double-blinded, placebo-controlled, parallel, multicenter clinical trial was conducted in 5 centers to compare the efficacy and safety of dexamethasone ointment with placebo. There were 810 patients with minor recurrent aphthous ulcerations screened for study eligibility, and 240 patients were enrolled at 5 centers from March 1, 2009 to April 30, 2010; 120 were assigned randomly to the treatment group and 120 to a control group. Patients were instructed to apply the given agent to the identified ulcer 3 times a day (after meals) for 5 days. The size, pain level, healing ratio, and average duration of ulcers and the safety of the agents were evaluated. The serum concentration of dexamethasone was detected using a high-performance liquid chromatography/mass spectrometry assay.

Results

The results showed that baseline characteristics were similar (P >.5). At day 6 ± 2 after treatment, there was significant difference in the variation of ulcer size between the treatment group (7.167 ± 6.3415 mm²) and the control group (4.346 ± 7.0666 mm²; P = .000); and in the variation of pain level between the treatment group (5.623 ± 1.9570) and the control group (4.940 ± 2.2449; P = .001). The healing ratio was 83.33% in the treatment group and 54.70% in the control group (P = .000). No severe adverse reactions were observed. No serum dexamethasone was detected before or after the use of the agents (<0.502 ng/mL).

Conclusion

Dexamethasone ointment was efficient in the treatment of recurrent aphthous ulceration and was safe as evaluated using clinical assessment and serum level detection.

Section snippets

Study Participants

The study was conducted in 5 centers (West China School of Stomatology, Sichuan University; Ninth People's Hospital, School of Stomatology, Shanghai Jiao Tong University School of Medicine; College of Stomatology, the Fourth Military Medical University; School & Hospital of Stomatology, Wuhan University; Zhongnan Hospital, Wuhan University) from March 1, 2009 to April 30, 2010. The planned start and end dates were the same for all centers. The inclusion criteria were: 1) age range of 18-60

Patients

There were 810 patients with minor recurrent aphthous ulceration screened for study eligibility. Among the 511 patients that did not meet the inclusion criteria, two thirds either had a duration of disease that exceeded 48 hours or were using agents for the treatment of recurrent aphthous ulceration. Another 59 subjects that met the inclusion criteria refused to participate in the study. Of the 240 patients that underwent randomization, 120 were assigned to the treatment group and 120 were

Discussion

Although oral ulcers occur in oral mucosa, in fact, they belong to the domain of internal medicine. They can present as simple oral ulcerations; they also can be the oral symptom of immunological diseases, or accompanied by systemic diseases.7, 8, 9, 10, 11, 12 To treat most oral ulcers, even accompanied with severe diseases of internal medicine, topical agents of corticosteroids are often chosen by physicians, and there are many reports on their use for the treatment of recurrent aphthous

Conclusions

The current study revealed that dexamethasone ointment was safe and efficient in reducing ulcer size, alleviating ulcer pain, and hastening ulcer healing in patients with recurrent aphthous ulceration. In addition, the patients had a good overall assessment of the agents. We could not detect dexamethasone in the serum of patients, which illustrated further the safety of dexamethasone ointment. Therefore, dexamethasone ointment is a candidate as an effective, adherent, and topical agent to treat

Acknowledgment

The authors acknowledge the contribution of all investigators who participated in this study and acknowledge the grant support of Jing Guan (Tianjin) International Trade Co., Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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: Funding: This work was supported by Jing Guan (Tianjin) International Trade Co., Ltd. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

: Conflict of Interest: None.

: Authorship: All authors had access to the data and played a role in writing this manuscript.

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Clinical research studyEfficacy and Safety of Dexamethasone Ointment on Recurrent Aphthous Ulceration

Abstract

Objective

Methods

Results

Conclusion

Section snippets

Study Participants

Patients

Discussion

Conclusions

Acknowledgment

Dent Clin North Am

Lancet

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Oral Surg Oral Med Oral Pathol

Oral Surg Oral Med Oral Pathol

Oral Surg Oral Med Oral Pathol

Oral Surg Oral Med Oral Pathol Oral Radiol Endod

Control Clin Trials

Acta Oto Esp

Respir Med

J Pharm Biomed Anal

Oral Surg Oral Med Oral Pathol

An exploration of point annual and lifetime prevalence in characterizing recurrent aphthous stomatitis in USA children and youths

J Oral Pathol Med

Aphthous ulceration

N Engl J Med

Treatment strategies for recurrent oral aphthous ulcers

Am J Health Syst Pharm

Number VI: recurrent aphthous stomatitis

Oral Dis

Etiology and management of recurrent aphthous stomatitis

Curr Infect Dis Rep

Crohn's disease masquerading as aphthous ulcers

Eur J Dermatol

Case records of the Massachusetts General HospitalCase 4-2010. A 53-year-old man with arthralgias, oral ulcers, vision loss, and vocal-cord paralysis

N Engl J Med

Autoimmunity in oral diseases, with special reference to recurrent oral ulceration

Proc R Soc Med

Clinical research study
Efficacy and Safety of Dexamethasone Ointment on Recurrent Aphthous Ulceration