Oral Cancer
Conditions
Brief summary
Objectives: To evaluate the effectiveness of green tea mouthwash on the oral health status (OHS) in oral cancer patients undergoing anticancer treatment. Materials and methods: This was a prospective, single-blind, randomized, controlled trial. Patients were randomly assigned to 2 groups: mouthwash with green tea (intervention) group or tap water (control) group. The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily, and the control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily. The primary outcome was OHS, which was evaluated according to the Oral Assessment Guide and measured at seven time points by the same researcher. Time 0 (T0) corresponded to baseline, and Time 1-6 (T1-T6) corresponded to monthly outpatient follow-ups until six months.
Interventions
OTHERmouthwash with green tea
All patients received instructions for using the Bass brushing method to brush their teeth with a soft small-headed toothbrush. The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily. For the preparation of the green tea mouthwash, green tea solution was made with 5 g (1 teaspoon) of green tea powder dissolved in 100 ml water to produce 5% green tea mouthwash, as described in a previous study (Eshghpour, et al., 2013). The green tea powder was ground from Camelia sinensis leaves and regularly provided by the researcher. The green tea solution is made for a single use and remade before rinsing each time. When patients return to the outpatient monthly, the researcher first confirms patients' compliance, then assists with solving difficulties and gives encouragement.
OTHERmouthwash with tap water group
All patients received instructions for using the Bass brushing method to brush their teeth with a soft small-headed toothbrush. The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
Sponsors
Chiayi Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Because of the nature of the intervention, only the data analyst was blinded to the meaning of the group assignment code.
Intervention model description
Patients were randomly assigned to 2 groups: mouthwash with green tea (intervention) group or tap water (control) group. The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily, and the control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who were \> 20 years * newly diagnosed with oral cancer by a physician * just received oral surgery and follow-up with or without chemotherapy or radiation therapy.
Exclusion criteria
* patients with mental illness * an acute and a severe illness status * no teeth in the whole mouth * the ability of mouth opening less than 1 cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| oral health status (OHS) | Time 0 (T0) corresponded to baseline | Patients' oral health status (OHS) was assessed according to the Oral Assessment Guide (OAG) by the same researcher. The OAG consists of eight items: voice, swallow, lips, tongue, saliva, mucous membranes, gingiva and teeth or dentures. Each item is rated by a grading of 1 (normal) to 3 (severe). Sum scores between 8-24 points and a higher score indicate poorer OHS. |
Countries
Taiwan
Outcome results
None listed