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

Primary Purpose

Oral Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
mouthwash with green tea
mouthwash with tap water group
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mouthwash with green tea group

mouthwash with tap water group

Arm Description

The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.

The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 27, 2020
Last Updated
November 3, 2020
Sponsor
Chiayi Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04615780
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Because of the nature of the intervention, only the data analyst was blinded to the meaning of the group assignment code.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mouthwash with green tea group
Arm Type
Experimental
Arm Description
The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily.
Arm Title
mouthwash with tap water group
Arm Type
Placebo Comparator
Arm Description
The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
Intervention Type
Other
Intervention Name(s)
mouthwash with green tea
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
mouthwash with tap water group
Intervention Description
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.
Primary Outcome Measure Information:
Title
oral health status (OHS)
Description
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 Frame
Time 0 (T0) corresponded to baseline
Title
oral health status (OHS)
Description
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 Frame
Time 1(T1) corresponded to the 1 month after recruitment.
Title
oral health status (OHS)
Description
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 Frame
Time 2(T2) corresponded to the 2nd month after recruitment.
Title
oral health status (OHS)
Description
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 Frame
Time 3(T3) corresponded to the 3th month after recruitment.
Title
oral health status (OHS)
Description
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 Frame
Time 4(T4) corresponded to the 4th month after recruitment.
Title
oral health status (OHS)
Description
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 Frame
Time 5(T5) corresponded to the 5th month after recruitment.
Title
oral health status (OHS)
Description
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 Frame
Time 6(T6) corresponded to the 6th month after recruitment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ditmanson Medical Foundation Chia-Yi Christian Hospital
City
Chiayi City
ZIP/Postal Code
60002
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34186380
Citation
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.
Results Reference
derived

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

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