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

September 2, 2021 updated by: Taipei Veterans General Hospital, Taiwan

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Beitou District
      • Taipei, Beitou District, Taiwan, 11217
        • Recruiting
        • Li ya-wen
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The participants assess the patient's oral health status by the oral health assessment tool scale.
Time Frame: to evaluate the seventh day after use green tea gargle
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The participants assess the patient's degree of halitosis by the portable breath meter.
Time Frame: to evaluate the seventh day after use green tea gargle
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".
Time Frame: to evaluate the seventh day after use green tea gargle
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Li ya-wen, Member

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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