| 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
|
|
|
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
|
|
|
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 NoDecay™ (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 NoDecay™ tablet on percentage reduction in Streptococcus mutans count in caries active children. |