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

Not Applicable

Completed

• Conditions: Oral Cancer
• Interventions: Other: mouthwash with tap water group; Other: mouthwash with green tea

• Registration Number: NCT04615780
• Lead Sponsor: Chiayi Christian Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Study First Posted: 2020-11-04
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mouthwash with tap water group	mouthwash with tap water group	The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
mouthwash with green tea group	mouthwash with green tea	The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.

Primary Outcome Measures

Name	Time	Method
oral health status (OHS)	Time 6(T6) corresponded to the 6th month after recruitment.	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.

Trial Locations

Locations (1)

Ditmanson Medical Foundation Chia-Yi Christian Hospital; 🇨🇳 Chiayi City, Taiwan