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

Lo-Sheng Sanatorium

Status: Completed

Conditions: Xerostomia; Plaque; Hansen's Disease; Leprosy

Treatments: Other: Traditional Chinese Medicine mouthwash; Other: Dilute 50 times of Traditional Chinese Medicine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT05091216

TH-IRB-0021-0012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Traditional Chinese Medicine Mouthwash Group

Experimental group

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.

Treatment:

Other: Traditional Chinese Medicine mouthwash

Dilute 50 times of Traditional Chinese Medicine Mouthwash Group

Active Comparator group

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.

Treatment:

Other: Dilute 50 times of Traditional Chinese Medicine mouthwash