| CTRI Number |
CTRI/2020/01/022762 [Registered on: 14/01/2020] Trial Registered Prospectively |
| Last Modified On: |
10/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Conservative management of mild to moderate molar-incisor hypomineralization |
|
Scientific Title of Study
|
Effectiveness of silver diammine fluoride in management of molar incisor hypomineralization |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RADHIKA CHOPRA |
| Designation |
PROFESSOR |
| Affiliation |
ITS-CDSR |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
8800977945 |
| Fax |
|
| Email |
drradhikachopra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RADHIKA CHOPRA |
| Designation |
PROFESSOR |
| Affiliation |
ITS-CDSR |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
UTTAR PRADESH
201206
India |
| Phone |
8800977945 |
| Fax |
|
| Email |
drradhikachopra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAKSHI JAIN |
| Designation |
PG STUDENT |
| Affiliation |
ITS-CDSR |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9560509262 |
| Fax |
|
| Email |
sakshi.jain7@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS-CDSR, MURADNAGAR, GHAZIABAD, UTTAR PRADESH
|
|
|
Primary Sponsor
|
| Name |
DR RADHIKA CHOPRA |
| Address |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR |
| 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 RADHIKA CHOPRA |
ITS-CDSR |
ROOM NO. 7, SECOND FLOOR, DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY, ITS-CDSR, DELHI-MEERUT ROAD, MURADNAGAR
Ghaziabad
UTTAR PRADESH |
8800977945
drradhikachopra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS-CDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with no systemic disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
38% Silver diammine fluoride |
Silver diammine fluoride on Hyomineralised molars will be topically applied for 2 min |
| Comparator Agent |
Silver Diammine Floride |
38% silver diammine fluoride will be compared with fluoride varnish. it will be applied topically on hypomineraized molar for 2 mins |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children having MIH with a score of 1, 3 and 2A, 4A in at least two permanent molars. Scoring criteria followed will be MIH Treatment Need Index |
|
| ExclusionCriteria |
| Details |
Children with severe MIH
Children with systemic diseases, intellectual disability, psychiatric disorders and dental abscesses or fistulas associated with the teeth of interest.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Silver diammine may reduce the severity of Molar Incisor Hypomineralization |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| With Silver diammine fluoride, there is less post-eruptive breakdown |
2 years |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| 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="2"
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)?
|
|
Brief Summary
|
This study is a randomized, parallel group, active controlled trial that will be comparing the effectiveness of 38% silver diammine fluoride and fluoride varnish in management of mild to moderate molar incisor hypomineralization with a follow up of 2 years. |