Brief Title
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
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.
Study Type
Interventional
Primary Outcome
oral health status (OHS)
Condition
Oral Cancer
Intervention
mouthwash with green tea
Study Arms / Comparison Groups
mouthwash with green tea group
Description: The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
61
Start Date
July 1, 2018
Completion Date
June 1, 2020
Primary Completion Date
June 1, 2020
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.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT04615780
Organization ID
10717
Responsible Party
Sponsor
Study Sponsor
Chiayi Christian Hospital
Study Sponsor
, ,
Verification Date
October 2020