| CTRI Number |
CTRI/2022/09/045445 [Registered on: 12/09/2022] Trial Registered Prospectively |
| Last Modified On: |
08/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the action of various varnishes like Nano Silver Fluoride, Chlorhexidine and Sodium fluoride on Streptococcus mutans level in Children with caries |
|
Scientific Title of Study
|
A comparative evaluation of Nano Silver Fluoride, Chlorhexidine and Sodium fluoride when used as a varnish on Streptococcus mutans levels in Children with Dental caries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tinesh Raja R R |
| Designation |
PG Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Room No.5, Department of Pediatric and Preventive Dentistry, Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar.
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
8056297817 |
| Fax |
|
| Email |
tineshraja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Agarwal |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Room No.5, Department of Pediatric and Preventive Dentistry, Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar.
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871262302 |
| Fax |
|
| Email |
doc.nagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Agarwal |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Room No.5, Department of Pediatric and Preventive Dentistry, Institute of Dental Studies and Technologies, NH-58, Kadrabad, Modinagar.
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871262302 |
| Fax |
|
| Email |
doc.nagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 5, Department of Pedodontics and Preventive Dentistry. Institute of Dental Studies and Technologies |
|
|
Primary Sponsor
|
| Name |
Dr Tinesh Raja R R |
| Address |
Institute of Dental Studies and Technologies, Kadrabad, Modinagar. |
| 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 Tinesh Raja R R |
Institute of Dental Studies and Technologies |
Room No.5, Department of Pedodontics and Preventive Dentistry
Ghaziabad
UTTAR PRADESH |
8056297817
tineshraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IDST Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine Varnish |
It contains 1% CHX and 1% Thymol. 1ml of solution will be applied once through topical application |
| Comparator Agent |
Control |
No Application |
| Intervention |
Nano Silver Fluoride |
It contains Nano silver particles (399.33µg/ml) , Fluoride (10,147µg/ml) and chitosan (2334µg/ml). 1 ml of NSF will will applied once through topical application |
| Comparator Agent |
Sodium Fluoride varnish |
It contains 5% Sodium Fluoride(22,600 ppm) and Xylitol.1 ml of solution will be applied once through topical application. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Co-operative children.
Children between 8 to 12 years of age with fully erupted Central incisors and First Molars.
Children having incipient caries.
Children having previous restoration.
No known history of allergy against silver particles.
|
|
| ExclusionCriteria |
| Details |
Presence of any intraoral infection/ pulpally involved teeth.
Children wearing orthodontic appliance.
Medically compromised, physically or mentally challenged children.
Children with history of antibiotic intake within one month prior to the study.
Children taking any fluoride treatment or using antimicrobial mouth rinse for the last 6month.
|
|
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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 |
| Assessment and Comparison of Oral Hygiene Index- Simplified, Assessment of S.mutans count in Plaque and Saliva |
AT BASELINE, 1 MONTH AND 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor the S.mutans count during the study period of 3 months |
Day 1 to 3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
15/09/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Children aged between 8 to 12 years will be selected for the study on the basis of selection criteria. They will be randomly divided into 4 equal groups. Group I, Group II, Group III and Group IV will be treated with Sodium Fluoride, Chlorhexidine and Nano Silver Fluoride as a varnish. Group I will act as a control group . OHI-S will be recorded, Plaque sample and Unstimulated salivary sample will be collected on the first visit, 1 month and 3 months after varnish application. |