| CTRI Number |
CTRI/2024/10/075062 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry
Other (Specify) [Toothpaste] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Toothpaste Brands for Kids Aged 3-6 and Their Parents Preferences |
|
Scientific Title of Study
|
Assessing Child And Parental Acceptability: A Double-Blind
Randomized Clinical Trial Comparing Two Toothpaste Brands Among
Children Aged 3-6 Years |
| 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 Shilpa Kochar |
| Designation |
Post Graduate Student |
| Affiliation |
Chhattisgarh Dental College & Research Institute |
| Address |
Dr. Shilpa Kochar 2nd year PG Student Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College & Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8965082875 |
| Fax |
|
| Email |
skochar023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagarathna PJ |
| Designation |
HOD & Dean |
| Affiliation |
Chhattisgarh Dental College & Research Institute |
| Address |
Dr. Nagarathna PJ Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College & Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9986889525 |
| Fax |
|
| Email |
drsiddu4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Kochar |
| Designation |
Post Graduate Student |
| Affiliation |
Chhattisgarh Dental College & Research Institute |
| Address |
Dr. Shilpa Kochar 2nd year PG Student Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College & Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8965082875 |
| Fax |
|
| Email |
skochar023@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhattisgarh Dental College and Research Institute Rajnandgaon Chhattisgarh |
|
|
Primary Sponsor
|
| Name |
Dr Shilpa Kochar |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
Rajnandgaon (C.G.) 491441
|
| 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 Shilpa Kochar |
Chhattisgarh dental college and research institute, Rajnanadgaon |
Department number 4, Department of Pedodontics and Preventive Dentistry
Rajnandgaon
CHHATTISGARH |
8965082875
skochar023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhattisgarh Dental College Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Heathy children aged 3-6 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. Pediflor Kidz(Green Apple flavour)
2. Kids Bunny (Strawberry flavour) |
The participants will be divided into two groups-
Group A will receive Toothpaste brand A
Group B will receive Toothpaste brand B
Each participant will be offered a coded oral hygiene kit containing the assigned toothpaste and a toothbrush. The soft-bristled toothbrush with uniform make was distributed to all participants to ensure uniformity in mechanical cleaning. The participants were instructed to brush their teeth with the assigned toothpaste manually using an educational video or animation on brushing technique used for
children i.e. fones technique for 3 min, 2 times a day, for 4 weeks, and to refrain from
using other oral hygiene products i At the end of 4 weeks following the intervention, all the participants will be assembled in a waiting room. The questionnaire will be filled out by the parents and collected.
|
| Intervention |
Toothpaste -
1. Pediflor kidz(green apple)
2. kids bunny(stawberry) |
The participants will be divided into two groups- Group A will receive Toothpaste brand A Group B will receive Toothpaste brand B Each participant will be offered a coded oral hygiene kit containing the assigned toothpaste and a toothbrush. The soft-bristled toothbrush with uniform make was distributed to all participants to ensure uniformity in mechanical cleaning. The participants were instructed to brush their teeth with the assigned toothpaste manually using an educational video or animation on brushing technique used for
children i.e. fones technique for 3 min, 2 times a day, for 4 weeks, and to refrain from
using other oral hygiene products. At the end of 4 weeks following the intervention, all the participants will be assembled in a waiting room. The questionnaire will be filled out by the parents and collected. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 3-6 years and their parents/guardians willing to participate in the study.
2. Children with no medical condition or allergy.
3. Children who can cooperate
|
|
| ExclusionCriteria |
| Details |
1. History of antibiotic use in the last 2 weeks
2. Those using mouth rinses containing chemical agents or inter-dental cleaning aids regularly.
3. Children with congenital anomalies, physical or mental disabilities
4. Children with known allergies or sensitivities to ingredients in the toothpaste brands being tested.
5. Children who are on regular medications or with special health needs.
|
|
|
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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.This study will shows the toothpaste acceptability, particularly in terms of taste, color and oral care needs, plays a key role in encouraging proper brushing habits in children.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. By considering child & parental preferences, toothpaste manufacturers can improve product compliance & support better oral health in children
|
6 months |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
23/10/2024 |
| 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="6"
Days="0" |
|
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
|
This study aims to compare two toothpaste brands among children aged 3-6 years, focusing on child and parental acceptability. The objectives include assessing children’s acceptability based on taste, texture, and color, and evaluating parental satisfaction regarding effectiveness and preference. The study is conducted at the Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College, involving 60 children who meet specific inclusion criteria. Children are randomly divided into two groups to use either Pediflor Kidz (Green Apple) or Kids Bunny (Strawberry) toothpaste. A double-blind, randomized clinical trial design ensures neither the participants nor the examiners know the toothpaste brands during the study. Parents provide informed consent, and children and parents follow specific brushing instructions. After four weeks of use, parents complete a questionnaire assessing the toothpaste based on factors like taste, texture, and overall satisfaction. Data is collected before, during, and after the trial, including oral health status, adverse events, and feedback on both the child’s and parent’s experiences. The study aims to provide insights into preferences for pediatric toothpaste, guiding future product recommendations. |