| CTRI Number |
CTRI/2024/08/072642 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Two Different Formulations of Xylitol used in children with early childhood caries to see the effect on Streptococcus mutans and Candida albicans |
|
Scientific Title of Study
|
Comparative Evaluation of Two Different Formulations of Xylitol on Streptococcus mutans and Candida albicans in Children with Early Childhood Caries: A 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 Simran Singh |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College, Hospital and Research Centre,47 Knowledge Park, Greater Noida |
| Address |
Room no-9, Department of Paediatric and Preventive Dentistry, ITS
Dental College, Hospital and Research Centre,47
Knowledge Park, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09717150985 |
| Fax |
|
| Email |
simran2022@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mousumi Goswami |
| Designation |
Professor and Head, Department of Paediatric and Preventive Dentistry |
| Affiliation |
ITS Dental College, Hospital and Research Centre,47 Knowledge Park, Greater Noida |
| Address |
Room no-9, Department of Paediatric and Preventive Dentistry, ITS
Dental College, Hospital and Research Centre,47
Knowledge Park, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8588854190 |
| Fax |
|
| Email |
mousumi87goswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Singh |
| Designation |
Post Graduate Student |
| Affiliation |
ITS Dental College, Hospital and Research Centre,47 Knowledge Park, Greater Noida |
| Address |
Room no-9, Department of Paediatric and Preventive Dentistry, ITS
Dental College, Hospital and Research Centre,47
Knowledge Park, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
09717150985 |
| Fax |
|
| Email |
simran2022@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College and Research Centre, 47 Knowledge Park III, Greater Noida, Uttar Pradesh, 201310 |
|
|
Primary Sponsor
|
| Name |
Dr Simran Singh |
| Address |
ITS Dental College and Research Centre 47,Knowledge
Park III, Greater Noida |
| Type of Sponsor |
Other [self] |
|
|
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 Simran Singh |
ITS dental college, hospital and research centre |
Room no-9,
Department of
Paediatric and
Preventive Dentistry,
ITS Dental
College, Hospital
and Research Centre,47 Knowledge Park, Greater Noida
Gautam Buddha Nagar,
Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
09717150985
-
simran2022@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S Dental College Hospital and Research Centre Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fluoridated toothpaste |
The intervention is done for 1 month after the enrollment of children with early childhood caries at the time of baseline. |
| Intervention |
Xylitol Wipes and Xylitol Toothpaste |
The intervention is done for 1 month after the enrollment of children with early childhood caries at the time of baseline. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 3-6 years.
2. Children with ECC, as per AAPD criteria
3. ASA I
4. Frankl Rating 3 & 4
5. Subjects willing to comply with the study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Children with systemic diseases or history of recent hospitalization
2. Consumption of antibiotics in the last 3 months.
3. Children who have previously used xylitol products regularly within the last 3 months.
4. Children lacking cooperative ability.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the reduction in colony counts of Streptococcus Mutans and Candida Albicans |
The outcome will be assessed at baseline, at 1 month and 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the reduction in plaque accumulation |
It will be assessed at baseline and at 1 month |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Enrollment of children of the age group 3-6 with
early childhood caries will be done using the inclusion and exclusion criteria
at the time of their first dental visit to the department. A total sample size of 44 (11 per group) is found to be sufficient for this Randomised Control Trial.Group Allocation:
Group 1: Fluoridated Toothpaste (FT) [Morning]
+ Xylitol Wipes (XW) [Before Sleeping]
Group 2: Fluoridated Toothpaste (FT) [Morning]
+ Placebo Wipes (PW) [Before Sleeping]
Group 3: Xylitol Toothpaste (XT) [Morning] +
Placebo Wipes (PW) [Before Sleeping]
Group 4: Xylitol Toothpaste (XT) [Morning] + Xylitol
Wipes (XW) [Before Sleeping] Salivary sample collection will be done at baseline, at 1 month and at 2 months to check the reduction in Streptococcus Mutans and Candida Albicans colony counts. Plaque accumulation will be assessed at baseline which is pre-intervention and at 1 month which is post-intervention. |