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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Oral Cancer

Intervention / Treatment
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* Other: mouthwash with green tea
* Other: mouthwash with tap water group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mouthwash with green tea group<br>The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily. | Other: mouthwash with green tea<br>* 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.<br>|
| Placebo Comparator: mouthwash with tap water group<br>The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily. | Other: mouthwash with tap water group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |