Clinical trial NCT04615780: Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: oral health status (OHS)
timeFrame: Time 0 (T0) corresponded to baseline
measure: oral health status (OHS)
timeFrame: Time 1(T1) corresponded to the 1 month after recruitment.
measure: oral health status (OHS)
timeFrame: Time 2(T2) corresponded to the 2nd month after recruitment.
measure: oral health status (OHS)
timeFrame: Time 3(T3) corresponded to the 3th month after recruitment.
measure: oral health status (OHS)
timeFrame: Time 4(T4) corresponded to the 4th month after recruitment.
measure: oral health status (OHS)
timeFrame: Time 5(T5) corresponded to the 5th month after recruitment.
measure: oral health status (OHS)
timeFrame: Time 6(T6) corresponded to the 6th month after recruitment.
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital
Study officials:
References:
citation: Liao YC, Hsu LF, Hsieh LY, Luo YY. Effectiveness of green tea mouthwash for improving oral health status in oral cancer patients: A single-blind randomized controlled trial. Int J Nurs Stud. 2021 Sep;121:103985. doi: 10.1016/j.ijnurstu.2021.103985. Epub 2021 May 25.