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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Clinical Study on the Effects of Traditional Chinese Medicine Mouthwash Solutions on the Oral Health of Leprosy Patients in Taiwan

Conditions
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Xerostomia, Leprosy, Hansen's Disease, Plaque

Intervention / Treatment
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* Other: Traditional Chinese Medicine mouthwash
* Other: Dilute 50 times of Traditional Chinese Medicine mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional Chinese Medicine Mouthwash Group<br>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. | Other: Traditional Chinese Medicine mouthwash<br>* 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.<br>|
| Active Comparator: Dilute 50 times of Traditional Chinese Medicine Mouthwash Group<br>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. | Other: Dilute 50 times of Traditional Chinese Medicine mouthwash<br>* Dilute 50 times of traditional Chinese medicine mouthwash.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index, PLI | Turesky modification of the Quigley-Hein Plaque Index (TQHPI) | 21 days | 
| Xerostomia questionnaire | Xerostomia questionnaire, Pai (2001) | 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leprosy, Hansen's disease (HD), traditional Chinese medicine mouthwash, oral health, xerostomia, Plaque Index, PLI