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

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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

, , 

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