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

NCT05037721 | Unknown

• 1 other identifier: 2021-01-021BC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Health

Keywords

green tea; gargling; oral health; stroke patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The participants assess the patient's degree of halitosis by the portable breath meter.

  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".

  to evaluate the seventh day after use green tea gargle

Study Arms (2)

gargling with green tea of stroke patients

EXPERIMENTAL

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

gargling with water of stroke patients

ACTIVE COMPARATOR

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

Interventions

gargling with green tea OTHER

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 green tea of stroke patients

gargling with water OTHER

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

gargling with water of stroke patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Li ya-wen

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Interventions

Tea; Water

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Li ya-wen

  member

  STUDY DIRECTOR

Central Study Contacts

Li ya-wen

CONTACT

28757161; ywli3@vghtpe.gov.tw

chung chi-Hui

CONTACT

Central Contact Backup:; iawen09@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: September 8, 2021
• Study Start: July 30, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)