Satheeshkumar, P. S., Chamba, M. S., Balan, A., Sreelatha, K. T., Bhatathiri, V. N., & Bose, T. (2010). Effectiveness of triclosan in the management of radiation-induced oral mucositis: a randomized clinical trial. Journal of Cancer Research and Therapeutics, 6(4), 466-472.10.4103/0973-1482.77109
To determine the effectiveness of triclosan in the management of radiation-induced oral mucositis.
To compare the effectiveness of triclosan mouth rinse with conventional sodium bicarbonate mouth rinse.
The trial group was comprised of 24 patients who were randomly allocated into two groups of 12 patients each. Patients in Group I were administered sodium bicarbonate mouth rinse and constituted the control group. Group II was the study group who was given triclosan mouth rinse. Allocation into arms was done with the help of a random number table.
The patients in the control group were advised to prepare sodium bicarbonate mouth rinse by dissolving 2 g of sodium bicarbonate powder, available with the chemist in lukewarm water. The triclosan mouth rinse used in the study was provided to the patient as a ready-made commercial mouth rinse.
Upon noticing the early signs of oral mucositis, patients were advised to begin using the mouth rinses. They were instructed to swish the mouth three times a day during the rest of the course of radiation treatment and continue the same regimen for six weeks following the completion of radiotherapy.
A weekly follow up of grading and mucositis (WHO grading), evaluation of body weight, food intake, and pain (visual analogue scale) were made during the radiation treatment period and post-radiation treatment period. Acute exacerbation of signs and symptoms, which could be attributed to reaction of the mouthwash, was also monitored during treatment.
The study was comprised of 24 patients. The median age in the control group was 65.9 years, and in the study group, the median age was 63.67 years.
Males (%): 29.1 in study group and 20.8 in control group. Females (%): 20.8 in study grup and 29.1 in control group.
Key Disease Characteristics: Histopathologically confirmed cases of oral squamous cell carcinoma, selected for external beam radiotherapy.
Site: Single site
Setting Type: The study was conducted in the radiation oncology department of a regional cancer center, Trivandrum in association with the Department of Oral Medicine and Radiology, Dental College.
Location: The center is locaed in Kerala, India.
Phase of Care: Active treatment
Twenty-four patients who underwent radiation therapy for oral cancer and subsequently developed oral mucositiis were included in the study.
WHO Grading scale for mucositis
Visual analogue scale for pain
Both the groups were statistically identical. All 24 patients in both groups passed through grade 3 mucositis on the last day of radiotherapy. However, 10 patients in the control group and only one patient in the study group entered to grade 4 mucositis. A definite change was noticed in the severity of mucositis, food intake, and weight loss. The control group took more than 45 days to resolve the mucositis, while the study group took only less than 28 days.
No firm conclusions regarding effects of triclosan mouthrinse can be made, due to study limitations.
The sodium bicarbonate mouthwash was needed to be prepared by the study participants, whereas the triclosan was given to the patients already prepared. This is a definite point that could influence compliance. There is no mention as to who did the oral assessments, one person or several different people. If several, was there consistency between them? Unknown.
There was no mention of compliance measurements of the study participant
Triclosan is used in periodontal therapy as an antibacterial agent; however, further research needs to be done to prove the effectiveness in the management of radiation-induced oral mucositis.