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

Not Applicable

Completed

• Conditions: Leprosy; Xerostomia; Plaque; Hansen's Disease
• Interventions: Other: Traditional Chinese Medicine mouthwash; Other: Dilute 50 times of Traditional Chinese Medicine mouthwash

• Registration Number: NCT05091216
• Lead Sponsor: Lo-Sheng Sanatorium

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.

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 Timeline

• Study First Submitted: 2021-09-29
• Study Start: 2021-10-01
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-10-25
• Primary Completion: 2022-09-06
• Study Completion: 2022-09-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine Mouthwash Group	Traditional Chinese Medicine mouthwash	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.
Dilute 50 times of Traditional Chinese Medicine Mouthwash Group	Dilute 50 times of Traditional Chinese Medicine mouthwash	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.

Primary Outcome Measures

Name	Time	Method
Plaque Index, PLI	21 days	Turesky modification of the Quigley-Hein Plaque Index (TQHPI)
Xerostomia questionnaire	21 days	Xerostomia questionnaire, Pai (2001)

Trial Locations

Locations (1)

Lo-Sheng Sanatorium; 🇨🇳 Taoyuan City, Taiwan