Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers

Abstract

Oral mucositis is a common side effect of chemo and radiotherapy causing painful ulcers in the oral mucosa. One of the preventive treatments recommended in international guidelines is oral cryotherapy (OC). Randomized clinical trials on OC have used ice and ice-chips to cool the mouth, but this cooling method can be difficult for the patients to tolerate. Studies have shown that OC with ice for a period of 60 min reduces the oral temperature by 12.9 °C. The aim of this pilot study was to evaluate the temperature reduction and tolerability of OC using an intra-oral air-cooling (IOAC) device in healthy volunteers. Twelve healthy volunteers, mean age 35.4 years, were included in the study. They were treated with OC using the IOAC device for 60 min. Measurements of temperature were obtained at baseline, 5 and 60 min using a FLIR® C2 camera. After the OC session, tolerability and adverse events were documented using a questionnaire. All participants were able to use the device for 60 min. The overall temperature reduction after 5 min of OC was 10.7°C (p < 0.01) and after 60 min 14.5°C (p < 0.01). The most common adverse events were bad fit of the mouthpiece (n = 6), hypersalivation (n = 6), and difficulties swallowing (n = 5). The oral device reduced the temperature of the oral mucosa as much as treatment with ice with tolerable adverse events. The mouthpiece will be remodeled to improve tolerability before further studies are conducted.

Randomized cross-over study investigating the tolerability and side effects of an intra-oral air-cooling device compared to ice in healthy volunteers

“…All participants completed the study protocol; both ice and air OC met the pre-defined tolerability criterion. Tolerability was similar or better than what has been previously reported for ice OC [ 24 – 26 ]. The most common side effects for ice OC were feeling cold, numbness, or pain in the mouth, probably related to the cooling effect of ice.…”

“…This indicates that air OC has the capacity to reduce the temperature in the oral mucosa to a degree that is clinically relevant. Larger temperature reductions accomplished by air OC have been demonstrated previously by our group [ 24 ]. This suggests that if the treatment is tolerable at the intended air flows, temperature reduction in the oral mucosa achieved by air OC is similar to that of ice OC.…”

“…In addition, increased salivation and dry mouth seem to affect participants more often with the IOAC device than with ice OC. This is probably related to the air flow, which we have previously reported [ 24 ].…”

“…We used a novel IOAC that was described for the first time in a previous study [ 24 ]. It consists of a cooling unit, a cooling delivery system, and a mouthpiece (Fig.…”

“…Treatment times of 30 to 60 min have been evaluated in randomized clinical trials [ 19 , 21 – 23 ]. The reported temperature reduction of the oral mucosa was 8.1–12.9 °C using ice chips and 14.5 °C for air OC [ 24 – 26 ]. However, no direct comparison between these two modalities has been performed.…”