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

Oral Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037721
• Other study ID #: 2021-01-021BC
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Li ya-wen
• Phone: 28757161
• Email: ywli3[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Health
• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	Li ya-wen	Taipei	Beitou District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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