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CTRI Number  CTRI/2018/09/015749 [Registered on: 18/09/2018] Trial Registered Prospectively
Last Modified On: 24/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Checking the cleaning ability of chlorhexidine, neem and triphala solution on fungus grown from complete denture 
Scientific Title of Study   A comparative evaluation of efficacy of chlorhexidine, triphala and neem on Candida albicans cultured from complete denture patients- A Randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karanpreet Singh 
Designation  Post Graduate student 
Affiliation  Manubhai Patel Dental College, Vadodara 
Address  Manubhai Patel Dental College, Near Vishwajyoti Ashram, Opp. Gujarat Tractors, Munjmahuda, Vadodara.

Vadodara
GUJARAT
390011
India 
Phone  8080750390  
Fax    
Email  mr.kay_92@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr N J Nirmal 
Designation  Prof P G guide 
Affiliation  Manubhai Patel Dental College, Vadodara 
Address  Manubhai Patel Dental College, Near Vishwajyoti Ashram, Opp. Gujarat Tractors, Munjmahuda, Vadodara.

Vadodara
GUJARAT
390011
India 
Phone  9825055957  
Fax    
Email  drnjnirmal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karanpreet Singh 
Designation  Post Graduate student 
Affiliation  Manubhai Patel Dental College, Vadodara 
Address  Manubhai Patel Dental College, Near Vishwajyoti Ashram, Opp. Gujarat Tractors, Munjmahuda, Vadodara.

Vadodara
GUJARAT
390011
India 
Phone  8080750390  
Fax    
Email  mr.kay_92@yahoo.co.in  
 
Source of Monetary or Material Support  
Karanpreet Singh, Manubhai Patel Dental College, vishwajyoti ashram, munjmahuda, Vadodara-390011  
 
Primary Sponsor  
Name  Karanpreet Singh 
Address  Manubhai Patel Dental College, Near Vishwajyoti Ashram, Opp. Gujarat Tractors, Munjmahuda, Vadodara- 390011 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Karanpreet Singh  Manubhai Patel Dental College  Department of Prosthodontics
Vadodara
GUJARAT 		 8080750390

mr.kay_92@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharaja Krishnakumarsinhji Bhavnagar University Ethics Committee for MDS Course and Dental Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  completely edentulous 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Triphala aqueous extract, Neem aqueous extract, 2% chlorhexidine  9% triphala aqueous extract, 9% neem aqueous extract, 2% chlorhexidine 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Individuals consenting to participate in the study.
Completely edentulous individuals
Individuals with complete denture
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Triphala, Neem and Chlorhexidine as denture cleaning agents  After 1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/09/2018 
Date of Study Completion (India) 07/12/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 


 
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