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

Oral Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615780
• Other study ID #: 10717
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: October 2020
• Source: Chiayi Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lip Neoplasms
• Mouth Neoplasms
• Oral Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oral health status (OHS)	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.	Time 0 (T0) corresponded to baseline
Primary	oral health status (OHS)	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.	Time 1(T1) corresponded to the 1 month after recruitment.
Primary	oral health status (OHS)	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.	Time 2(T2) corresponded to the 2nd month after recruitment.
Primary	oral health status (OHS)	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.	Time 3(T3) corresponded to the 3th month after recruitment.
Primary	oral health status (OHS)	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.	Time 4(T4) corresponded to the 4th month after recruitment.
Primary	oral health status (OHS)	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.	Time 5(T5) corresponded to the 5th month after recruitment.
Primary	oral health status (OHS)	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.	Time 6(T6) corresponded to the 6th month after recruitment.