| CTRI Number |
CTRI/2021/02/031288 [Registered on: 15/02/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of early initial caries using two types of paste which fights against cavities |
|
Scientific Title of Study
|
EFFECTIVENESS OF TWO REMINERALIZING AGENTS IN MANAGEMENT OF THE WHITE SPOT LESIONS - A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NAMBI NATCHIYAR S |
| Designation |
Postgraduate student |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Room number 9,
Department of Pediatric and Preventive Dentistry,
KSR Institute of Dental Science and Research
Namakkal.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843928611 |
| Fax |
|
| Email |
natchisrither@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharath Asokan |
| Designation |
Principal and Guide |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Principal and Guide,
Room number 9,
Department of Pediatric and Preventive Dentistry,
KSR Institute of Dental Science and Research.
Namakkal.
Namakkal
TAMIL NADU
637215
India |
| Phone |
9840168772 |
| Fax |
|
| Email |
asokansharath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nambi Natchiyar S |
| Designation |
MDS (second year postgraduate) |
| Affiliation |
KSR INSTITUTE OF DENTAL SCIENCE AND RESEARCH |
| Address |
Room no 9,
Department of Pediatric and Preventive Dentistry
KSR Institute of Dental Science and Research
Namakkal
Namakkal
TAMIL NADU
637215
India |
| Phone |
9843928611 |
| Fax |
|
| Email |
natchisrither@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Kailasam memorial primary school, Tirumalaiappapuram.
PottalPudur, Tamil Nadu 627473 |
|
|
Primary Sponsor
|
| Name |
Nambi Natchiyar S |
| Address |
KSR Institute of Dental Science and Research |
| 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 |
| Nambi Natchiyar S |
Sri Kailasam memorial primary school |
Room number 3,
Tirumalaiappapuram,
Tirunelveli - Shencottai Road, PottalPudur 627473
Tirunelveli
TAMIL NADU |
9843928611
natchisrither@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee KSR Institute of Dental Science and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening and Intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Remineralization agents |
Embrace varnish
Duration of application- few seconds
Amount- 1500rs / 10 sachets
rupees
Amount to be used - 0.25ml |
| Intervention |
Remineralizing agents |
Self assembling peptide p11-4
Duration of application- 5 minutes application for material peneteration
Price- 10sachets 10,000
rupees
Amount to be used - 0.1ml/tooth |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
With active visible white spot lesions in upper anteriors |
|
| ExclusionCriteria |
| Details |
- With any systemic problems
- Used any other remineralizing agent other than regular toothpaste in the past 6 months were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Remineralization of white spot lesions based on ICDAS score, photographic morphometric analysis and permeability changes in enamel done using Scanning Electron Microscope |
3 months and 6 months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Permeability changes in enamel using Scanning Electron Microscope |
6 months follow-up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Manuscript preparation |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Effectiveness of remineralization in children aged 3 to 5 years with active visible white spot lesions in upper anteriors and analyze the effect of remineralization using ICDAS, photographic morphometric analysis and enamel permeability differences using Scanning Electron Microscope |