Reviewed: Atashi V, Reviewed: Yazdannik A, Mahjobipoor H, Ghafari S, Bekhradi R, Yousefi H. The effects of Aloe vera-peppermint (Veramin) moisturizing gel on mouth dryness and oral health among patients hospitalized in intensive care units: a triple-blind randomized placebo-controlled trial. J Res Pharm Pract. April-June 2018;7(2):104-110. doi: 10.4103/rpp.JRPP_18_21.
Dry mouth is common among patients in hospital intensive care units (ICUs). It can be caused by endotracheal or orogastric tubes and can be worsened by restricted fluid intake associated with certain respiratory, cardiac, and renal conditions. Dry mouth can lead to oral mucositis and gingivitis, cavities and plaque, and bacterial growth in the mouth and throat. It also can predispose patients to developing pneumonia.
Aloe vera (Aloe vera, Asphodelaceae) inner leaf gel contains ingredients that can improve skin and mucosa hydration and help heal wounds. Peppermint (Mentha × piperita, Lamiaceae) leaf essential oil has antibacterial, cooling, and pain-relieving effects. The authors conducted a randomized, triple-blind, placebo-controlled clinical trial to analyze the effects of the moisturizing gel Veramin® (Barij Essence Pharmaceutical Company; Kashan, Iran), which contains aloe vera inner leaf gel and peppermint essential oil, on mouth dryness and oral health in patients in ICUs.
Patients eligible for the study were hospitalized from November 2016 to August 2017 in the ICU of a teaching hospital in Isfahan, Iran. They were 18 to 65 years of age, had an endotracheal tube in place through the mouth, had been in the ICU for less than 24 hours, and had not been in another hospital ward before being admitted to the ICU. They did not have a history of autoimmune disorders, pneumonia, or sepsis; were not sensitive to herbs; did not wear dentures; and had no lesions in or around the mouth.
Eighty patients were randomly and equally assigned to be treated with either Veramin or placebo. Veramin gel contains aloe vera inner leaf gel, peppermint essential oil, carboxymethyl cellulose, propylene glycol, and potassium sorbate. The placebo gel was carboxymethyl cellulose-based, and contained propylene glycol, potassium sorbate, and water. A 0.12% chlorhexidine solution was used to brush the inner and outer surfaces of the teeth and tongue every 12 hours. The Veramin and placebo gels were applied every four hours to the oral mucosa, gums, and tongue after brushing.
The primary outcome was reduction of mouth dryness, which was assessed by a dentist at baseline and on days three and five of the study by using the visual Challacombe Scale, which scores dryness from 1 to 10, with higher scores representing more severe dryness. The secondary outcome was oral health as measured by using the Mucosal-Plaque Score, with higher scores indicating poor oral health.
No baseline between-group differences were seen in age, gender, chronic health conditions, antacid consumption, cigarette smoking, or feeding route. During the study, one patient died and one patient was weaned from the ventilator in the Veramin group. In the placebo group, two patients died during the study. Thirty-eight patients in each group were included in the final analysis, and no adverse effects were reported during the study.
Results of the Mann-Whitney U test, a statistical measure for population differences, revealed that at baseline, mouth dryness scores were significantly higher in the Veramin group compared with the placebo group (P = 0.0001). At day three, the between-group difference was not significant (P = 0.551); however, at day five, mouth dryness was significantly less in the Veramin group compared with the placebo group (P = 0.0001). Within-group analyses indicated a significant decrease in the mean score of mouth dryness in the Veramin group (P = 0.0001) and no significant change in the placebo group by day five.
The Mann-Whitney U test revealed a significantly higher oral health score in the Veramin group at baseline compared with the placebo group (P = 0.026); however, the score in the Veramin group was significantly lower than in the placebo group on day three (P = 0.003) and on day five (P = 0.0001). The mean score for oral health significantly decreased from baseline to day five in the Veramin group (P = 0.0001); the change in the oral health score in the placebo group was not significant.
Limitations of this study include the short follow-up period, the relatively small sample size, a limited definition of oral health, and the use of a single location.
The authors concluded that “Veramin moisturizing gel is effective in significantly relieving mouth dryness, preventing dental plaque formation, and improving oral health” and “can be used for improving oral care outcomes in ICUs.”