NCT04615780

Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients

Effectiveness of Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients: A Single-blind Randomized Clinical Trial and a CONSORT-compliant Article

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Chiayi Christian Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oral Cancer

Interventions

Type	Name	Description
OTHER	mouthwash 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.
OTHER	mouthwash 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.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2020-11-04
• Last updated: 2020-11-04

Locations

1 site across 1 country: Taiwan