Madan, P.D., Sequeira, P.S., Shenoy, K., & Shetty, J. (2008). The effect of three mouthwashes on radiation-induced oral mucositis in patients with head and neck malignancies: A randomized control trial. Journal of Cancer Research Therapies, 4(1), 3–8.

The effect of three test mouthwashes and a control were studied.

1. 0.12% chlorhexidine
2. 1% povidone-iodine
3. salt/sodium bicarbonate
4. plain water (control)

Coloring agents, sweeteners, and flavoring agents were added to the mouthwashes so that all had identical color and taste. All were alcohol free.

Patients rinsed mouths with 10 ml of mouthwash BID for six weeks. Patients swished for about two minutes and expectorated, then abstained from eating or gargling for 30 minutes.
 

The study was comprised of 20 patients in each arm of study.

Adult patients with stage II–IV head and neck malignancy scheduled to receive RT of 60 Gy or higher, delivered in 30 fractions over a six-week period.

At least one-third of oral cavity mucosa was included in the radiation field.

Powered for 20 subjects in each arm; 76 completed.

The median age was 54.25–58.2 years.

More men participated than women.
 

July 2003–January 2004

Double-blind, placebo-controlled, randomized clinical trial

Compliance was assessed weekly by checking the level of mouthwash left in bottles.

Mucositis WHO– single examiner

Primary endpoint of study was the end of week 6.
 

Significant difference in mean mucositis scores was observed among all four groups. Post hoc analysis for repeated measure showed a statistically significant difference between the povidone group and control group (p = 0.013) at the end of week 1.

At the end of week 2, povidone, chlorhexidine, and salt/soda groups differed significantly from the control group.

At the end of week 4, significant differences also were observed between the povidone and salt/soda groups (p = 0.16).

At the end of week 5, significant differences were observed between all test groups and the control group. Differences also were observed within test groups.

At the end of week 6, a slightly different trend was observed. Significant differences were observed between the povidone group and all other groups; difference in mucositis among other groups was not statistically significant.
 

Although the volume of solution used was checked weekly, data does not indicate compliance.

No data is available regarding treatment delay.