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CTRI Number  CTRI/2017/04/008314 [Registered on: 07/04/2017] Trial Registered Prospectively
Last Modified On: 18/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic
Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to find out the effectiveness of probiotics added to denture sticking powder in reducing fungal infection inside the oral cavity in a denture wearing patient and its effect on retention of the denture. 
Scientific Title of Study   Comparative evaluation of the effect of denture adhesives with probiotics on colony forming units of candida and retention in completely edentulous patients wearing complete dentures. A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tamanna M Chhabra 
Designation  Reader 
Affiliation  K M Shah Dental College 
Address  Room no. 9,,Department of Prosthodontics,K M Shah Dental College, Sumandeep Vidyapeeth,Piparia,Waghodia

Vadodara
GUJARAT
391760
India 
Phone  8758868392  
Fax  08758868392  
Email  drtamannachhabra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J R Patel 
Designation  Dean and Professor 
Affiliation  Narsinghbhai Patel Dental college and Hospit 
Address  18,sadabhav Bunglows,Opp.Om Tower,Ghoda Camp Road, Shahibaug,Ahmedabad
Narsinghbhai Patel Dental college and Hospital,Sankalchand Patel University ,S K Campus,Kamana Cross Road, Visnagar 384315
Ahmadabad
GUJARAT
380004
India 
Phone  09824045092  
Fax  09824045092  
Email  drjrpatel33@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Tamanna M Chhabra 
Designation  Reader 
Affiliation  K M Shah Dental College 
Address  Room No.9,Department of Prosthodontics, K M Shah Dental College,Sumandeep Vidyapeeth,Piparia,Waghodia

Vadodara
GUJARAT
391760
India 
Phone  8758868392  
Fax  08758868392  
Email  drtamannachhabra@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Tamanna M Chhabra 
Address  D-8, Sumandeep Vidyapeeth Camus,Piparia,Waghodia, Vadodadara, Gujarat. 391760 
Type of Sponsor  Other [Individual ,PhD Thesis] 
 
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 
Tamanna M Chhabra  K M Shah Dental College and Hospital  Room No. 9 ,Department of Prosthodontics,Sumandeep Vidyapeeth,Piparia,Waghodia.391760
Vadodara
GUJARAT 		 8758868392
8758868392
drtamannachhabra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K121||Other forms of stomatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Plain Denture Adhesive  patient will sprinkle plain powder denture adhesive on the denture surface three times daily for 5 weeks. 
Intervention  Probiotics,Lactobacillus acidophillus Lactobacillus rhamnosus Bifidobactreium total strength of 10 raised to 8. 3gms of probiotic added to 15gms of adhesives.  patient will sprinkle adhesive powder on the surface of denture three times daily for 5 weeks. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  a.Completely edentulous patients
b. Patients who will be not using antibiotics, antifungals or probiotics in any form.
c. Patients who will be asymptomatic candida carriers in oral cavity
d. Patients who will understand and will be ready to be part of the study 
 
ExclusionCriteria 
Details  a. Patients suffering from any chronic debilitating disorder
b. Inability to understand and be part of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Colony forming unit of candida CFU/ul
2. Retention of upper denture N-cm 		 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
there are no secondary outcomes  there are no secondary outcomes 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/03/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomised controlled trial with a cross over design to find out the effect of probiotics added to denture adhesives on the colony forming units of candida in the oral cavity in complete denture wearers and its effect on retention of the denture . It has been proved that probiotics bring down the candida infection level  in oral cavity in complete denture patients.A trial product was generated where probiotics of the total power of 10raise to power 8 containing lactobacillus rhamnosus,lactobacillus acidophilus and bifidobacterium bifidum. the primary outcome assessed will be CFU/uL and retention in Complete denture patients in N-Cm.  Candida is a normal commensal of the oral cavity but it can become can turn pathogenic in patients who are immunocompromised.Denture adhesives enhance retention in the dentures.Therefore they are commonly prescribed in denture wearing patients. It has also been shown that denture adhesives can increase the risk of candida in denture wearing patients if they do not maitain hygiene adequately. therefore there was need to generate a product which can enhance the retention of the denture at the same time prevent candida growth under the denture in healthy and in immunocompromised patients. 
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