Back to resultsEffects of Gargling With Green Tea on Oral Health of Stroke Patients
Primary Purpose
Oral Health
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
gargling with green tea
gargling with water
Sponsored by
About this trial
This is an interventional other trial for Oral Health focused on measuring green tea, gargling, oral health, stroke patients
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients over 20 years of age with acute cerebral stroke admitted by medical institutions.
- Stroke patients diagnosed by medical institutions were treated with the National Institute of Health Stroke Scale; NIHSS) score is 5-15, which is a moderate degree of stroke
- Able to perform mouthwash.
- Those who have passed the three-stage swallowing function screening.
- Those with stable medical condition.
Exclusion Criteria:
- Those who of medical institutes in the diagnosis of severe alzheimer.(ICD-10 code： G30.9)
- Those who severe mental retardation.
- Those has a history of mental illness.
- Those has unable to clearly express their wishes.
- Those has full mouth teeth less than six.
- Those has in the past more than a month use mouthwash.
- Those has treatment of the patients with gingivitis and periodontal disease, oral antibiotics or anti-fungal drugs.
- Those has unable to cooperate or applicable except of assessment tools.
Sites / Locations
- Li ya-wenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
gargling with green tea of stroke patients
gargling with water of stroke patients
Arm Description
Use fresh green tea (package date less than one month) sourced from the local market and serve in the form of soaked tea bags. 0.5% green tea refers to a tea bag soaked in 0.5g green tea, soaked in 100ml warm water for 5 minutes and let cool. Then, put each bottle of 15ml mouthwash into a disposable opaque bottle, and give two bottles of mouthwash required daily at one time. Use 15ml twice a day, 30 minutes after breakfast and 30 minutes after lunch, each time for 30 seconds. Rinse mouth up and down for 30 seconds. Rinse mouth up and down, half sitting and lying down, and shake the head of bed for 30 degrees. After breakfast, the experimental group and the control group were instructed to clean their teeth according to routine procedures, and telephone reminders were provided to inform them to gargle.
Use water 15ml of mouthwash into a disposable opaque bottle, and give two bottles of mouthwash required daily at one time. Use 15ml twice a day, 30 minutes after breakfast and 30 minutes after lunch, each time for 30 seconds. Rinse mouth up and down for 30 seconds. Rinse mouth up and down, half sitting and lying down, and shake the head of bed for 30 degrees. After breakfast, the experimental group and the control group were instructed to clean their teeth according to routine procedures, and telephone reminders were provided to inform them to gargle.
Outcomes
Primary Outcome Measures
The participants assess the patient's oral health status by the oral health assessment tool scale.
Oral Health Assessment Tool (OHAT) kayser-Jones et al. (1995) Oral Health of elderly and cognitively impaired persons. A Brief Oral Health 6 Status Examination was developed. BOHSE) and may be evaluated by a nursing practitioner. Chalmers, Johnson, Tang and Titler developed the Oral Health Assessment Tool (OHAT) after modifying the Simple Oral Health Status Measurement Scale in 2004. This scale can be extended to assess the oral health of elderly people with daily living function dependence, and can be assisted by clinical nursing staff after guidance. The contents of the questionnaire were divided into eight items, including lips, tongue, gums, toothache, saliva, teeth, dentures and oral hygiene. The degree of oral health was divided by 0, 1 and 2 points for each item. The total score ranged from 0 to 16, the higher the score was, the worse the oral health was.
Secondary Outcome Measures
The participants assess the patient's degree of halitosis by the portable breath meter.
In this study, a portable breath meter (HC-150®, Tanita Co, Tokyo, Japan) was used to measure the concentration of volatile sulfide in the mouth of patients with a score ranging from 0 to 5. The higher the score, the more severe the halitosis. Manner to ensure that the portable measuring instrument measured the stability of the data, before the study, to perform 20 minutes five patients repeated measurement mouth sulfide values, the research process are made by same nurses within non-executive care plan for all the object of study manner using a portable measuring instrument for testing, in order to maintain consistency measurement. The portable breath meter is calibrated by the instrument to determine the accuracy of the measured value.
The participants assess the patient's the degree of dental plaque with the modified plaque index of "Turesky".
In 1962, quigley-Hein developed a plaque index score of 0 to 5 and stained with plaque stains. In 1970, Turesky et al. improved the method. After staining with plaque stains, they scored according to the stained area. The scoring criteria were as follows: 0 was for plaque free; 1. There are scattered punctate dental plaque at the gingival margin of the tooth neck; 2: the width of dental plaque in the neck is less than 1mm(continuous); 3: dental plaque covering area of the tooth neck is more than 1mm, less than 1/3 of the tooth face; 4: the area covered by dental plaque is between 1/3 and 2/3 of the teeth; 5. The dental plaque covers more than 2/3 of the teeth. To distinguish the degree of dental plaque, the total score is 2 points. When the index is greater than 2, it is high; when the index is between 0 and 1, it is low. The higher the score is, the worse the oral health is.
Full Information
NCT ID
NCT05037721
First Posted
August 4, 2021
Last Updated
September 2, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05037721
Brief Title
Effects of Gargling With Green Tea on Oral Health of Stroke Patients
Official Title
Oral Health Initiative With Green Tea,Gargling,Oral Health for Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
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
Compare the effects of gargling with green tea on the oral health of stroke patients?
Compare whether gargling with green tea can reduce halitosis in stroke patients?
Compare whether gargling with green tea can reduce plaque index in stroke patients?
Detailed Description
Before the intervention of green tea mouthwash, patients in the experimental group and the control group were tested for oral health status, bad breath and plaque degree, and received routine brushing guidelines. Patients in the experimental group received green tea mouthwash intervention twice a day for 7 day
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health
Keywords
green tea, gargling, oral health, stroke patients
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gargling with green tea of stroke patients
Arm Type
Experimental
Arm Description
Use fresh green tea (package date less than one month) sourced from the local market and serve in the form of soaked tea bags. 0.5% green tea refers to a tea bag soaked in 0.5g green tea, soaked in 100ml warm water for 5 minutes and let cool. Then, put each bottle of 15ml mouthwash into a disposable opaque bottle, and give two bottles of mouthwash required daily at one time. Use 15ml twice a day, 30 minutes after breakfast and 30 minutes after lunch, each time for 30 seconds. Rinse mouth up and down for 30 seconds. Rinse mouth up and down, half sitting and lying down, and shake the head of bed for 30 degrees. After breakfast, the experimental group and the control group were instructed to clean their teeth according to routine procedures, and telephone reminders were provided to inform them to gargle.
Arm Title
gargling with water of stroke patients
Arm Type
Active Comparator
Arm Description
Use water 15ml of mouthwash into a disposable opaque bottle, and give two bottles of mouthwash required daily at one time. Use 15ml twice a day, 30 minutes after breakfast and 30 minutes after lunch, each time for 30 seconds. Rinse mouth up and down for 30 seconds. Rinse mouth up and down, half sitting and lying down, and shake the head of bed for 30 degrees. After breakfast, the experimental group and the control group were instructed to clean their teeth according to routine procedures, and telephone reminders were provided to inform them to gargle.
Intervention Type
Other
Intervention Name(s)
gargling with green tea
Intervention Description
experimental group using 0.5% green tea gargle, control group use clear water gargle, secondary in daily use mouthwash after breakfast and lunch after 30 minutes, 15 ml each use gargle for 30 seconds, total 7 days
Intervention Type
Other
Intervention Name(s)
gargling with water
Intervention Description
using water gargle, control group use clear water gargle, secondary in daily use mouthwash after breakfast and lunch after 30 minutes, 15 ml each use gargle for 30 seconds, total 7 days
Primary Outcome Measure Information:
Title
The participants assess the patient's oral health status by the oral health assessment tool scale.
Description
Oral Health Assessment Tool (OHAT) kayser-Jones et al. (1995) Oral Health of elderly and cognitively impaired persons. A Brief Oral Health 6 Status Examination was developed. BOHSE) and may be evaluated by a nursing practitioner. Chalmers, Johnson, Tang and Titler developed the Oral Health Assessment Tool (OHAT) after modifying the Simple Oral Health Status Measurement Scale in 2004. This scale can be extended to assess the oral health of elderly people with daily living function dependence, and can be assisted by clinical nursing staff after guidance. The contents of the questionnaire were divided into eight items, including lips, tongue, gums, toothache, saliva, teeth, dentures and oral hygiene. The degree of oral health was divided by 0, 1 and 2 points for each item. The total score ranged from 0 to 16, the higher the score was, the worse the oral health was.
Time Frame
to evaluate the seventh day after use green tea gargle
Secondary Outcome Measure Information:
Title
The participants assess the patient's degree of halitosis by the portable breath meter.
Description
In this study, a portable breath meter (HC-150®, Tanita Co, Tokyo, Japan) was used to measure the concentration of volatile sulfide in the mouth of patients with a score ranging from 0 to 5. The higher the score, the more severe the halitosis. Manner to ensure that the portable measuring instrument measured the stability of the data, before the study, to perform 20 minutes five patients repeated measurement mouth sulfide values, the research process are made by same nurses within non-executive care plan for all the object of study manner using a portable measuring instrument for testing, in order to maintain consistency measurement. The portable breath meter is calibrated by the instrument to determine the accuracy of the measured value.
Time Frame
to evaluate the seventh day after use green tea gargle
Title
The participants assess the patient's the degree of dental plaque with the modified plaque index of "Turesky".
Description
In 1962, quigley-Hein developed a plaque index score of 0 to 5 and stained with plaque stains. In 1970, Turesky et al. improved the method. After staining with plaque stains, they scored according to the stained area. The scoring criteria were as follows: 0 was for plaque free; 1. There are scattered punctate dental plaque at the gingival margin of the tooth neck; 2: the width of dental plaque in the neck is less than 1mm(continuous); 3: dental plaque covering area of the tooth neck is more than 1mm, less than 1/3 of the tooth face; 4: the area covered by dental plaque is between 1/3 and 2/3 of the teeth; 5. The dental plaque covers more than 2/3 of the teeth. To distinguish the degree of dental plaque, the total score is 2 points. When the index is greater than 2, it is high; when the index is between 0 and 1, it is low. The higher the score is, the worse the oral health is.
Time Frame
to evaluate the seventh day after use green tea gargle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients over 20 years of age with acute cerebral stroke admitted by medical institutions.
Stroke patients diagnosed by medical institutions were treated with the National Institute of Health Stroke Scale; NIHSS) score is 5-15, which is a moderate degree of stroke
Able to perform mouthwash.
Those who have passed the three-stage swallowing function screening.
Those with stable medical condition.
Exclusion Criteria:
Those who of medical institutes in the diagnosis of severe alzheimer.(ICD-10 code： G30.9)
Those who severe mental retardation.
Those has a history of mental illness.
Those has unable to clearly express their wishes.
Those has full mouth teeth less than six.
Those has in the past more than a month use mouthwash.
Those has treatment of the patients with gingivitis and periodontal disease, oral antibiotics or anti-fungal drugs.
Those has unable to cooperate or applicable except of assessment tools.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li ya-wen
Phone
28757161
Email
ywli3@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
chung chi-Hui
Phone
Central Contact Backup:
Email
iawen09@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li ya-wen
Organizational Affiliation
member
Official's Role
Study Director
Facility Information:
Facility Name
Li ya-wen
City
Taipei
State/Province
Beitou District
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ya-wen Li, bachelor
Phone
+886228757161
Email
ywli3@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
chi-Hui chchung, bachelor
Phone
+886228712121
Email
chchung2@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Gargling With Green Tea on Oral Health of Stroke Patients
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