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CTRI Number  CTRI/2020/02/023667 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 17/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Anti-streptococcus antibody containing tablet on Streptococcus mutans count, causative factor of dental caries. 
Scientific Title of Study   Effect of commercially available anti-streptococcus IgY containing tablet on Streptococcus mutans count in caries active children: In vivo study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishvas Patil 
Designation  Professor 
Affiliation  Dr D Y Patil Vidyapeeth 
Address  Department of Pedodontics and Preventive Dentistry Dr D Y Patil Dental College and Hospital

Pune
MAHARASHTRA
411018
India 
Phone  9822529424  
Fax    
Email  docvishwaspatil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ADITI MATHUR 
Designation  Associate Professor 
Affiliation  DR D Y PATIL VIDYAPEETH 
Address  Department of Pedodontics and Preventive Dentistry Dr D Y Patil Dental College and Hospital

Pune
MAHARASHTRA
411018
India 
Phone  8376055529  
Fax    
Email  drmathuradi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aditi mathur 
Designation  Associate Professor 
Affiliation  Dr D Y Patil Vidyapeeth 
Address  Department of Pedodontics and Preventive Dentistry Dr D Y Patil Dental College and Hospital

Pune
MAHARASHTRA
411018
India 
Phone  8376055529  
Fax    
Email  drmathuradi@gmail.com  
 
Source of Monetary or Material Support  
Inzpera Healthsciences Ltd A Subsidiary of Tata Industries Limited 407 Summit Business Bay Andheri Mumbai 400093 
 
Primary Sponsor  
Name  Inzpera Healthsciences Ltd A Subsidiary of Tata Industries Limited 
Address  407 Summit Business Bay Andheri Mumbai 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
DrVishvas Patil  Dr. D.Y Patil Dental College and Hospital  Department of Pedodontics and Preventive Dentistry OPD Room Number-10 Dr.D.Y Patil Dental College
Pune
MAHARASHTRA 
9822529424

docvishwaspatil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE Dr.D.Y PATIL VIDYAPEETH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL Single Arm Study  NIL 
Intervention  NoDecay Chew able Tablet   The tablet contains Egg Yolk protein powder (Delipidated), Mannitol, Maltitol, Xylitol, cross carmellose sodium, peppermint, orange flavour, microcrystalline cellulose, steviol glycoside, magnesium stearate, talc and colour. The tablets have been recommended for children above 5 years of age and to be used twice daily. 
Comparator Agent  Placebo  Nil 
Comparator Agent  Placebo  The tablet contains Mannitol, Maltitol, Xylitol, cross carmellose sodium, peppermint, orange flavour, microcrystalline cellulose, steviol glycoside, magnesium stearate, talc and colour. The tablets have been recommended for children above 5 years of age and to be used twice daily. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients having 5 active carious teeth.
Patients not requiring antibiotics.
No systemic illness and pathology.  
 
ExclusionCriteria 
Details  Use of systemic Antibiotics in last 30 days.
Use of mouthwash in last 30 days.
Allergic to egg.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percent reduction in S Mutants count after administration of NoDecay chew able tablet.   1st day, 30th day, 90th day, 120th day, 180th day  
 
Secondary Outcome  
Outcome  TimePoints 
Carious Lesion   1. 90 Days
2. 180 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   02/03/2020 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Despite exhaustive research and advances in oral health sciences, dental caries still remains as one of the most prevalent afflictions in modern man, affecting humans of all ages, especially children where caries disease is on the rise.  Great strides have been made in understanding the pathogenesis of dental caries. Infection as a key component in the etiology of caries was uncovered around 110 years ago by Miller who made the link among microorganisms, dietary carbohydrates, and dental caries.

Although molecular, biological and cultural techniques have also implicated role of other bacteria in the process and extension of dental caries in, S mutans continues to be Enemy of teeth #1, especially for early childhood dental disease.  The infectious nature of dental caries imprecates the hypothesis that some form of host immunity can regulate caries activity.

Several attempts to develop successful vaccine against dental caries have been undertaken in the past three decades. However immunogenic antigens of Streptococcus mutans share epitopes with human IgG and cross react with human rheumatoid anti-IgG antibodies.  An immunological intervention for prevention of caries other than the vaccination is passive immunization. This has a considerable advantage as it completely avoids any risk that may arise from active immunization.

 

Strategies include the development of antibodies to Mutans streptococcal antigens in cow’s milk and hen’s eggs and the genetic engineering of human-like S-IgA antibodies in plants. Successful passive immunization has been done in rats using orally administered hen yolk antibodies against Streptococcus mutans1 and topical anti- streptococcus mutans IgY gel.

 

Studies on human volunteers have demonstrated reduction in Streptococcus mutans count when mouth-rinse containing IgY against S. mutans whole cell antigen and cell associated glucosyl transferase enzyme was used. Tooth paste incorporated with anti S. mutans IgY was found to be effective in reducing caries in deciduous teeth in human volunteers .

Recently chewable tablets containing IgY against Streptococcus mutans have been launched by the trade name of NoDecayâ„¢ (Inzpera Healthsciences Limited). The tablet contains Egg Yolk protein powder (Delipidated), Mannitol, Maltitol, Xylitol, cross carmellose sodium, peppermint, orange flavour, microcrystalline cellulose, steviol glycoside, magnesium stearate, talc and colour. The tablets have been recommended for children above 5 years of age and to be used twice daily.

The present study is undertaken to evaluate the efficacy of NoDecayâ„¢ tablet on percentage reduction in Streptococcus mutans count in caries active children.

 
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