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

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque; Xerostomia; Leprosy; Hansen's Disease
• Intervention / Treatment: Other: Traditional Chinese Medicine mouthwash; Other: Dilute 50 times of Traditional Chinese Medicine mouthwash

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 33351
    • Lo-Sheng Sanatorium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Chinese Medicine Mouthwash Group; 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; 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.
Active Comparator: Dilute 50 times of Traditional Chinese Medicine Mouthwash Group; 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; Dilute 50 times of traditional Chinese medicine mouthwash.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lo-Sheng Sanatorium
• Investigators: Principal Investigator: Wei-Hung Hsu, Lo-Sheng Sanatorium

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: oral health; xerostomia; Leprosy; Hansen's disease (HD); traditional Chinese medicine mouthwash; Plaque Index, PLI
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Mouth Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Salivary Gland Diseases; Xerostomia; Leprosy
• Other Study ID Numbers: TH-IRB-0021-0012

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