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

NCT05091216 | Completed

• 1 other identifier: TH-IRB-0021-0012
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Leprosy; Hansen's Disease; Xerostomia; Plaque

Keywords

Leprosy; Hansen's disease (HD); traditional Chinese medicine mouthwash; oral health; xerostomia; Plaque Index, PLI

Outcome Measures

Primary Outcomes (2)

• Plaque Index, PLI

  Turesky modification of the Quigley-Hein Plaque Index (TQHPI)

  21 days

• Xerostomia questionnaire

  Xerostomia questionnaire, Pai (2001)

  21 days

Study Arms (2)

Traditional Chinese Medicine Mouthwash Group

EXPERIMENTAL

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

Dilute 50 times of Traditional Chinese Medicine Mouthwash Group

ACTIVE COMPARATOR

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

Interventions

Traditional Chinese Medicine mouthwash OTHER

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.

Traditional Chinese Medicine Mouthwash Group

Dilute 50 times of Traditional Chinese Medicine mouthwash OTHER

Dilute 50 times of traditional Chinese medicine mouthwash.

Dilute 50 times of Traditional Chinese Medicine Mouthwash Group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lo-Sheng Sanatorium: lead

Study Sites (1)

Lo-Sheng Sanatorium

Taoyuan, 33351, Taiwan

Location

MeSH Terms

Conditions

Leprosy; Xerostomia; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei-Hung Hsu

  Lo-Sheng Sanatorium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of chinese medicine

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 25, 2021
• Study Start: October 1, 2021
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)