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

Chiayi Christian Hospital

Status: Completed

Conditions: Oral Cancer

Treatments: Other: mouthwash with green tea; Other: mouthwash with tap water group

Study type: Interventional

Funder types: Other

Identifiers

NCT04615780

10717

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups, including a placebo group

mouthwash with green tea group

Experimental group

Description:

The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.

Treatment:

Other: mouthwash with green tea

mouthwash with tap water group

Placebo Comparator group

Description:

The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.

Treatment:

Other: mouthwash with tap water group