Effects of Gargling With Green Tea on Oral Health of Stroke Patients

Oral Health Initiative With Green Tea,Gargling,Oral Health for Stroke Patients

1. Compare the effects of gargling with green tea on the oral health of stroke patients?
2. Compare whether gargling with green tea can reduce halitosis in stroke patients?
3. Compare whether gargling with green tea can reduce plaque index in stroke patients?

Study Overview

• Status: Recruiting
• Conditions: Oral Health
• Intervention / Treatment: Other: gargling with green tea; Other: gargling with water

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

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li ya-wen; Phone Number: 28757161; Email: ywli3@vghtpe.gov.tw
• Study Contact Backup: Name: chung chi-Hui; Phone Number: Central Contact Backup:; Email: iawen09@gmail.com

Study Locations

• Taiwan
  • Beitou District
    • Taipei, Beitou District, Taiwan, 11217
      • Recruiting
      • Li ya-wen
      • Contact: ya-wen Li, bachelor; Phone Number: +886228757161; Email: ywli3@vghtpe.gov.tw
      • Contact: chi-Hui chchung, bachelor; Phone Number: +886228712121; Email: chchung2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gargling with green tea of stroke patients; 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.	Other: gargling with green tea; 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
Active Comparator: gargling with water of stroke patients; 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.	Other: gargling with water; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	to evaluate the seventh day after use green tea gargle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	to evaluate the seventh day after use green tea gargle
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.	to evaluate the seventh day after use green tea gargle

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Director: Li ya-wen, Member

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: oral health; gargling; green tea; stroke patients
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2021-01-021BC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No