Checking the cleaning ability of chlorhexidine, neem and triphala solution on fungus grown from complete denture

Completed

• Conditions: completely edentulous

• Registration Number: CTRI/2018/09/015749
• Lead Sponsor: Karanpreet Singh

Brief Summary

Regular cleaning of dentures is recognized as an important part of oral hygiene for denture wearers. Several studies suggest that up to two-thirds or more of individuals who wear removable complete dentures can suffer from denture stomatitis. Relationship of denture stomatitis has been accounted for mucosal injury because of poor denture fit, expanding age of the denture client, expanded time of dentures, bacterial and parasitic (basically Candida) contamination, and poor denture cleanliness. The importance of maintaining denture hygiene is to eliminate pathogenic microorganisms’ counts to prevent the reestablishment of a pathogenic biofilm, as well.

Promotion of the existing resources is what is required to gain confidence of people and to motivate them to maintain their oral hygiene. There is a need to test the anticandidal efficacy of the easily available products such as triphala and neem as denture cleansers. Though many studies are conducted on the antifungal effect of chlorhexidine, but there is less documentation or data regarding the use of neem and triphala as denture cleansers against Candida albicans. Hence this study was undertaken with the aim of comparing the anticandidal efficacy of *Triphala, Neem* and Chlorhexidine for complete dentures patients.

**The null hypothesis-**

- There is no significant difference between the anticandidal efficacy of *Triphala*and Chlorhexidine for complete denture patients.

- There is no significant difference between the anticandidal efficacy of *Neem*and Chlorhexidine for complete denture patients.

- There is no significant difference between the anticandidal efficacy of *Triphala*and *Neem* for complete denture patients.

 **Procedure**

**-**A total of 60 individuals’ denture will be examined.  The subjects will be divided into three groups by chit system, 20 individuals in each, Group A- Triphala, Group B- Neem and Group C- Chlorhexidine. The partiipants will be informed about the nature of the investigation; and written informed consent will be obtained prior to enrolment.

 **Sample collection before using the solution**-

- Pre-sterilized swab will be used for sample collection from the palatal region of intaglio surface of the denture. The collected sample will be sent for microbiological investigation.

 **Sample collection after using the chlorhexidine/ Triphala/ Neem solution**-

- Individuals will be asked to use the denture during daytime for the next 30 days. they will be instructed to add the chlorhexidine/ triphala/ neem solution in water and immerse their denture in it at night and use their denture during the day. They will be recalled for second and third sample collection on the 15th and the 30th day respectively.

 The results obtained will be subjected to the following statistical analysis-Descriptive analysis (mean, standard deviation, CI), One-way ANOVA and Post HOC test.

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-07-12
• Study Start: 2018-09-25
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Individuals consenting to participate in the study.
• Completely edentulous individuals Individuals with complete denture.

Exclusion Criteria

• Individuals with a known allergy to materials used in this study.
• Individuals who are unable to come for the follow-up.
• Individuals suffering from xerostomia Individuals with denture stomatitis.
• Individuals with history of oral candidiasis, or predispose to Candidal carriage (such as diabetes mellitus, anemia, immune-debilitating disease) Individuals using antifungal agents or antiseptic mouthwashes over the past one month.
• Individuals using any medication known to predispose to oral candidiasis, e.g. steroid therapy or antibiotics over the last one month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microbiological evaluation of Candida albicans colony forming units	Day 1- Baseline sample (before using the solution) | Day 15- Second sample (15 days after using the solution) | Day 30- third sample (30 days after using the solution)

Secondary Outcome Measures

Name	Time	Method
Triphala, Neem and Chlorhexidine as denture cleaning agents	After 1 month

Trial Locations

Locations (1)

Manubhai Patel Dental College; 🇮🇳 Vadodara, GUJARAT, India

Manubhai Patel Dental College

🇮🇳Vadodara, GUJARAT, India

Karanpreet Singh

Principal investigator

8080750390

mr.kay_92@yahoo.co.in