| CTRI Number |
CTRI/2024/02/062692 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effectiveness and acceptability of the fluoridated toothpaste to prevent plaque and gum diseases in
children in the age group of 6 to 12 years |
|
Scientific Title of Study
|
To evaluate the efficacy and acceptability of the fluoridated toothpaste in its anti-plaque and anti-gingivitis
properties in a pediatric population in the age group of 6 to 12 years – A non- randomized active controlled clinical 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 Ashok Dhoble |
| Designation |
BDS, MDS, Orthodontics and Dentofacial Orthopedics |
| Affiliation |
Indian Dental Association |
| Address |
Dr APJ Abdul Kalam Education Research and Incubation Center
Indian Dental Association
3rd Floor Unit no3A and B Zone 1 DGP House
88C Old Prabhadevi Road
Prabhadevi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400025
India |
| Phone |
9820094499 |
| Fax |
|
| Email |
ashokdhoble@ida.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Dhoble |
| Designation |
BDS, MDS, Orthodontics and Dentofacial Orthopedics |
| Affiliation |
Indian Dental Association |
| Address |
Dr APJ Abdul Kalam Education Research and Incubation Center
Indian Dental Association
3rd Floor Unit no3A and B Zone 1 DGP House
88C Old Prabhadevi Road
Prabhadevi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400025
India |
| Phone |
9820094499 |
| Fax |
|
| Email |
ashokdhoble@ida.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Dhoble |
| Designation |
BDS, MDS, Orthodontics and Dentofacial Orthopedics |
| Affiliation |
Indian Dental Association |
| Address |
Dr APJ Abdul Kalam Education Research and Incubation Center
Indian Dental Association
3rd Floor Unit no3A and B Zone 1 DGP House
88C Old Prabhadevi Road
Prabhadevi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400025
India |
| Phone |
9820094499 |
| Fax |
|
| Email |
ashokdhoble@ida.org.in |
|
|
Source of Monetary or Material Support
|
| AVODEN PRIVATE LIMITED
512 TO 516, WEST FACE,
OPP. BLACK SALT
RESTAURANT, NR.
BAGHBAN PARTY PLOT,
THALTEJ, AHMEDABAD,
Ahmedabad, Gujarat, 380054 |
|
|
Primary Sponsor
|
| Name |
Avoden pvt ltd |
| Address |
512 TO 516 WEST FACE OPP BLACK SALT RESTAURANT NR
BAGHBAN PARTY PLOT THALTEJ AHMEDABAD Ahmedabad
Gujarat 380054
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Minal Kumthekar |
Dr APJ Abdul Kalam Education Reserach and Incubation Center |
Indian Dental Association (Head Office)
3rd Floor, Unit no.3A & B, Zone 1, DGP House,
88C Old Prabhadevi Road,
Prabhadevi, Mumbai - 400 025
Mumbai (Suburban)
MAHARASHTRA |
8390888047
minal.dentist@gmail.com |
| Dr Sushant Mohanty |
Institute of Dental Sciences |
Institute of Dental Sciences, K8 Kalinga Nagar, Sum Hospital Road, Bhubaneswar 751003, Dist Khurda, Odisha
Anugul
ORISSA |
9437037512
dr.susantmohanty@gmail.com |
| DR MANISH KHATRI |
Institute of Dental Studies and Technologies |
IDST, NH 58, DELHI MEERUT ROAD, KADRABAD, MODINAGAR
Ghaziabad
UTTAR PRADESH |
9810720335
drmanishkhatri@yahoo.com |
| Dr Sayli Vichare |
MGM Dental College & Hospital, |
Junction of NH4 & Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai 410209
Raigarh
MAHARASHTRA |
8108420130
saylirk1991@gmail.com |
| Dr Sirisha sirbonia |
SIBAR Institute of dental sciences |
SIBAR Institute of dental sciences, Takkellapadu, Guntur-522509, Andhra Pradesh
Guntur
ANDHRA PRADESH |
898919513034
sirishasiriboina15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| DR APJ ABDUL KALAM EDUCATION RESEARCH CENTSEARCH CENTRE AND SUPERSPECIALITY DENTAL CLINIC |
Approved |
| Institute of Dental Studies & Technologies Ethics Committee |
Approved |
| Institutional Ethics committee - Institute of Dental Sciences |
Approved |
| Institutional Ethics committee, MGM Dental College & Hospital, Kamothe, Navi Mumbai |
Submittted/Under Review |
| Institutional ethics committee, SIBAR institute of dental sciences. |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diseases of oral cavity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Colgate toothpaste - standard commercially available |
Tooth paste to be used for
brushing twice daily for 3
months
|
| Intervention |
Dentoshine toothpaste |
Tooth paste to be used for
brushing twice daily for 3
months
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with plaque score 1
Subjects with gingival scores 1 and 2
Subjects showing signs of mild marginal gingival inflammation
Subjects parent or guardian who agree to comply with all study requirements and are able to follow the study directions. |
|
| ExclusionCriteria |
| Details |
gingival scores more than 2
orthodontic bands and five or more carious lesions
History of allergies
Subject on antibiotics
Subject with five or more carious lesions requiring immediate restorative treatment |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the plaque and gingival scores
Changes in the clinical signs of gingival inflammation
Changes in the clinical signs of gingival inflammation
|
Plaque and gingival score to be assessed at 1 monthi.e at 1st followup 2 months i.e at2nd followup and 3 months i.e at 3rd followup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Understanding products acceptability through survey data points |
acceptability and tolerability to be assessed after 1 month |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
26/02/2024 |
| 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="3"
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
|
T The study is a randomized controlled trial to check for the efficacy and acceptability of fluoridated toothpaste in a pediatric population. This study will be conducted across five centers in India with a total sample size of 300 pediatric patients. The primary outcome of the study is changes in the plaque and gingival scores and changes in the clinical signs of gingival inflammation. The secondary outcome is understanding products acceptability and tolerability through survey data points |