Skip to main content
OpenTrials
Completed

NCT Number: NCT05091216

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Hansen's Disease Infections Mouth Diseases Mycobacterium Infections Mycobacterium Infections, Nontuberculous Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque Plaque, Amyloid Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lo-Sheng Sanatorium

Taoyuan City, 33351, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Dilute 50 times of Traditional Chinese Medicine mouthwash

Other

Dilute 50 times of traditional Chinese medicine mouthwash.

Primary outcomes

  1. Plaque Index, PLI

    Time frame: 21 days

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

  2. Xerostomia questionnaire

    Time frame: 21 days

    Xerostomia questionnaire, Pai (2001)

Sponsors and collaborators

Lead sponsor

Lo-Sheng Sanatorium

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.