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The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients

Primary Purpose

Leprosy, Hansen's Disease, Xerostomia

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional Chinese Medicine mouthwash
Dilute 50 times of Traditional Chinese Medicine mouthwash
Sponsored by
Lo-Sheng Sanatorium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leprosy focused on measuring Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan
  • Compliant with the presence of more than four teeth in each of the upper and lower four regions
  • Those who have not used antibiotics and mouthwash two months before the test

Exclusion Criteria:

  • Moderate to severe dementia
  • CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more
  • Those with a score of less than 17 on the MMSE Simple Mind Scale
  • Nasogastric Tube Inserters
  • Those who are allergic to mouthwash
  • Those who are on course of antibiotics and steroids
  • Those who have had dental cleansing within one month

Sites / Locations

  • Lo-Sheng SanatoriumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Traditional Chinese Medicine Mouthwash Group

Dilute 50 times of Traditional Chinese Medicine Mouthwash Group

Arm Description

The subjects use traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.

The subjects use dilute 50 times traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.

Outcomes

Primary Outcome Measures

Plaque Index, PLI
Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Xerostomia questionnaire
Xerostomia questionnaire, Pai (2001)

Secondary Outcome Measures

Full Information

First Posted
September 29, 2021
Last Updated
October 20, 2021
Sponsor
Lo-Sheng Sanatorium
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1. Study Identification

Unique Protocol Identification Number
NCT05091216
Brief Title
The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients
Official Title
A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lo-Sheng Sanatorium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to treat with traditional Chinese medicine mouthwash, and through the research of dental plaque detection and xerostomia questionnaire and traditional Chinese medicine treatment mechanism.
Detailed Description
The study will recruit 58 patients who are hospitalized at Lo-Sheng Sanatorium, Ministry of Health and Welfare. Investigators will use xerostomia questionnaire and PLI examination to collect the subject's data. Separate subjects in to two group randomly. The control group will use the traditional Chinese medicine mouthwash, and the other group will use the dilute 50 times of traditional Chinese medicine mouthwash. Every 7 days will record the PLI value and conduct a xerostomia questionnaire, until 21 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy, Hansen's Disease, Xerostomia, Plaque
Keywords
Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional Chinese Medicine Mouthwash Group
Arm Type
Experimental
Arm Description
The subjects use traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.
Arm Title
Dilute 50 times of Traditional Chinese Medicine Mouthwash Group
Arm Type
Active Comparator
Arm Description
The subjects use dilute 50 times traditional Chinese medicine mouthwash after three meals a day and before going to bed, four times a day for 7 consecutive days. After 7 days, record the PLI value and conduct a xerostomia questionnaire, and then retrieve the mouthwash bottle the remaining dose was checked to determine compliance. Those with significantly poor compliance were excluded from the experiment, and then the daily cleaning measures were resumed. The subjects still followed the way of mouthwash four times a day until the end of the 21st day after the xerostomia questionnaire.
Intervention Type
Other
Intervention Name(s)
Traditional Chinese Medicine mouthwash
Intervention Description
The mouthwash used in this test is based on the records of past traditional Chinese medicine classics and the existing antibacterial experimental evidence. The selected medicinal materials are honeysuckle, scutellaria, peppermint, licorice, and rhizome.
Intervention Type
Other
Intervention Name(s)
Dilute 50 times of Traditional Chinese Medicine mouthwash
Intervention Description
Dilute 50 times of traditional Chinese medicine mouthwash.
Primary Outcome Measure Information:
Title
Plaque Index, PLI
Description
Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Time Frame
21 days
Title
Xerostomia questionnaire
Description
Xerostomia questionnaire, Pai (2001)
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents of Lo-Sheng sanatorium of the Ministry of Health and Welfare, Taiwan Compliant with the presence of more than four teeth in each of the upper and lower four regions Those who have not used antibiotics and mouthwash two months before the test Exclusion Criteria: Moderate to severe dementia CDR (Clinical Dementia Assessment Scale) is greater than or equal to 2 points or more Those with a score of less than 17 on the MMSE Simple Mind Scale Nasogastric Tube Inserters Those who are allergic to mouthwash Those who are on course of antibiotics and steroids Those who have had dental cleansing within one month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-yi Chen
Phone
+886282006600
Ext
2506
Email
ls01120@lslp.mohw.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Hung Hsu
Organizational Affiliation
Lo-Sheng Sanatorium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lo-Sheng Sanatorium
City
Taoyuan City
ZIP/Postal Code
33351
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Yi Chen
Phone
+886282006600
Ext
2506
Email
ls01120@lslp.mohw.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients

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