Green Tea Mouthwash on the Oral Health Status in Oral Cancer Patients
NCT ID: NCT04615780
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2018-07-01
2020-06-01
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mouthwash with green tea group
The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.
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
The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* newly diagnosed with oral cancer by a physician
* just received oral surgery and follow-up with or without chemotherapy or radiation therapy.
Exclusion Criteria
* an acute and a severe illness status
* no teeth in the whole mouth
* the ability of mouth opening less than 1 cm.
20 Years
ALL
No
Sponsors
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Chiayi Christian Hospital
OTHER
Responsible Party
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Locations
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Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, , Taiwan
Countries
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References
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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.
Other Identifiers
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10717
Identifier Type: -
Identifier Source: org_study_id