| CTRI Number |
CTRI/2019/07/020163 [Registered on: 12/07/2019] Trial Registered Prospectively |
| Last Modified On: |
10/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of a water resistant material and a normal material in terms of lastingness to prevent tooth decay. |
|
Scientific Title of Study
|
Comparison of retention of a moisture tolerant pit and fissure sealant with resin based conventional pit and fissure sealant. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerthy S |
| Designation |
Post graduate student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry
The Oxford Dental College
1Oth Milestone
Hosur road
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
7760705946 |
| Fax |
|
| Email |
keerthys94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhusudhan S |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry
The Oxford Dental College
1Oth Milestone
Hosur road
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9886298680 |
| Fax |
|
| Email |
madhusudhan6009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Keerthy S |
| Designation |
Post graduate student |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Public Health Dentistry
The Oxford Dental College
1Oth Milestone
Hosur road
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
7760705946 |
| Fax |
|
| Email |
keerthys94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored.
The oxford dental college |
|
|
Primary Sponsor
|
| Name |
Dr Keerthy S |
| Address |
Department of Public Health Dentistry
The Oxford Dental College
1Oth Milestone
Hosur road
Bangalore |
| 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 Keerthy |
The Oxford dental college |
Department of Public Health Dentistry, 3rd floor, room number 6.
Bangalore
KARNATAKA |
7760705946
keerthys94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford Dental Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with Increased Risk of Dental Caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Pit and Fissure Sealant |
3M Clinpro Pit and Fissure Sealant |
| Intervention |
Moisture Tolerant Pit and Fissure sealant
|
Pulpdent Embrace Wetbond Pit and Fissure Sealant |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
High dental caries risk prone children |
|
| ExclusionCriteria |
| Details |
Children with one molar on either side which is grossly carious or restored.
Uncooperative children/children not willing to participate
Molar teeth with antagonist tooth not present or extracted
Children with dental fluorosis
Children with habits like bruxism
Children with rampant caries
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention rate of the sealants |
3, 6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
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 4 |
|
Date of First Enrollment (India)
|
31/07/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a double blind split mouth randomized controlled trial where the retention rate of moisture tolerant pit and fissure sealant will be compared with conventional pit and fissure sealant on 6-9 year old school children of SVET high school, Begaluru. The hypothesis being there is a difference in the retention rate of moisture tolerant pit and fissure sealant when compared to conventional pit and fissure sealant. |