| CTRI Number |
CTRI/2024/11/076114 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of Antibody toothpaste, Anticaries toothpaste and regular toothpaste against bacteria in saliva |
|
Scientific Title of Study
|
Comparative evaluation of Antibacterial efficacy of Immunoglobulin Y (IgY) toothpaste, Fluoridated toothpaste and non-Fluoridated toothpaste on salivary Streptococcus mutans - A double-blind, Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Angel Abisha S |
| Designation |
Post graduate student |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry
Best Dental Science College
69/1 Ultra nagar Chennai Highway Madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
9629963203 |
| Fax |
|
| Email |
angel96stephen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subhashini M |
| Designation |
Reader |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry
Best Dental Science College
69/1 Ultra nagar Chennai Highway Madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
9629975348 |
| Fax |
|
| Email |
doctor.subhashini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Palanivel Pandian |
| Designation |
Professor |
| Affiliation |
Best Dental Science College |
| Address |
Department of Public Health Dentistry
Best Dental Science College
69/1 Ultra nagar Chennai Highway Madurai
Madurai
TAMIL NADU
625104
India |
| Phone |
9677995966 |
| Fax |
|
| Email |
palanivelpandian@gmail.com |
|
|
Source of Monetary or Material Support
|
| Best Dental Science College,
Ultra nagar, Madurai-Chennai Highway, Madurai, Tamilnadu- 625104
India |
|
|
Primary Sponsor
|
| Name |
Best Dental Science College |
| Address |
Ground Floor
Room No 2
Department of Public Health Dentistry
Madurai
Tamilnadu - 625104
India |
| Type of Sponsor |
Other [Private Dental College and Hospital] |
|
|
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 |
| Dr Angel Abisha S |
Milton Matriculation Higher Secondary School |
2nd floor,
room no 1,
28QG+28F Melur-Azhagarkovil Road
Melur
Surakkundu
Madurai - 625106
Madurai
TAMIL NADU |
9629963203
angel96stephen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Best Dental Science College - Instituitional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Devoid of any Oral diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoridated toothpaste |
Toothpaste form
0.25 grams of toothpaste to be used twice daily for 45 days |
| Intervention |
Immunoglobulin Y (IgY) toothpaste |
Toothpaste form
0.25 grams of toothpaste to be used twice daily for 45 days |
| Comparator Agent |
Non-Fluoridated toothpaste |
Toothpaste form
0.25 grams of toothpaste to be used twice daily for 45 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
12 to 15 years of age
Both male and female are included
Caries active individuals (Caries active individuals are those who have at least one carious tooth surface)
Subjects who are willing to follow the instructions given during the course of study
|
|
| ExclusionCriteria |
| Details |
Subjects who have received antibiotics 2 weeks prior to the study.
Subjects using other oral hygiene aids like Mouthwash, dental floss, water floss.
Subjects with systemic illness.
Subjects with history of allergy to egg.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bacterial count of Streptococcus mutans |
45 days after using respective toothpaste |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in colony count of bacteria Streptococcus mutans |
15th day after using respective toothpaste
30th day after using respective toothpaste |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 4 |
|
Date of First Enrollment (India)
|
17/11/2024 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dental caries is a multifactorial disease which mainly results from reactions among oral flora, susceptible host and diet. Streptococcus mutans and Lactobacillus are the two main cariogenic bacteria causing dental caries. Although Fluoride plays an important role in anti-caries effect, its role is only limited. Hence a newer method of passive immunization was introduced to act against streptococcus mutans. This passive immunization with immunoglobulin y obtained from yolk of chicken egg is highly active against streptococcus mutans. This study aims to assess and compare the Antibacterial efficacy of Immunoglobulin Y (IgY) toothpaste, Fluoridated toothpaste and non-Fluoridated toothpaste on salivary Streptococcus mutans. |