| CTRI Number |
CTRI/2019/02/017504 [Registered on: 06/02/2019] Trial Registered Prospectively |
| Last Modified On: |
05/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
To study the improvement of esthetic appearance/discoloration of teeth affected with fluorosis using different techniques |
|
Scientific Title of Study
|
To evaluate the clinical efficacy of resin infiltration technique alone or in combination with micro abrasion or in-office bleaching in discoloured teeth with mild to moderate fluorosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mandeep s grewal |
| Designation |
Head of department of conservative dentistry and endodontics |
| Affiliation |
SGT dental college hospital and research institute |
| Address |
SGT dental college hospital and research institute chandu budhera gurgaon
5804 aster avenue DLF phase 4 gurgaon 122002
Gurgaon
HARYANA
122505
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mandeep s grewal |
| Designation |
Head of department of conservative dentistry and endodontics |
| Affiliation |
SGT dental college hospital and research institute |
| Address |
SGT dental college hospital and research institute chandu budhera gurgaon
5804 aster avenue DLF phase 4 gurgaon 122002
Gurgaon
HARYANA
122505
India |
| Phone |
9810805880 |
| Fax |
|
| Email |
drmandeepsgrewal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poorvi saxena |
| Designation |
post graduate student of department of conservative dentistry and endodontics |
| Affiliation |
SGT dental college hospital and research institute |
| Address |
B 203 lovely home apartment plot 5 sector 5 dwarka
B 306 lovely home apartment plot 5 sector 5 dwarka
South West
DELHI
110075
India |
| Phone |
9695046479 |
| Fax |
|
| Email |
saxenapoorvi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMG Dental Material Gesellschaft mbH Elbgaustrabe 248
22547 Hamburg Germany |
| SGT dental college chandu budhera gurgaon 122505 haryana India |
|
|
Primary Sponsor
|
| Name |
SGT dental college hospital and research institute |
| Address |
chandu budhera gurgaon 122505 haryana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mandeep s grewal |
SGT dental college hospital and research institute |
Department of conservative dentisry and endodontics faculty of dental sciences room number 5 chandu budhera gurgaon 122505 haryana
Gurgaon
HARYANA |
9810805880
drmandeepsgrewal@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee of SGT dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fluorosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Icon (DMG germany) |
resin infiltration material frequency of which will be used once in each group and applied topically and depending on procedure duration it will be either used in single visit or after 15 days interval |
| Comparator Agent |
opalusture (ultradent) |
micro abrasion frequency of which will be used once in second and third group and applied topically and depending on procedure duration will be used in single visit |
| Comparator Agent |
pola office bleach (SDI) |
bleaching frequency of which will be used once in third group and applied topically and depending on procedure duration it will be used in single visit |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients from fluoride endemic areas were selected with non-carious and non-restored teeth |
|
| ExclusionCriteria |
| Details |
patients with history of allergy towards any dental material and who had undergone any treatment for dental fluorosis earlier. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in tooth discoloration |
immediately after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| tooth sensitivity |
immediately after treatment, after 24 hours and after 1 week |
| patient satisfaction |
after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2019 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
patients having fluorosis will be treated using resin infiltration alone and in combination with microabrasion and bleaching. Three calibrated and blind examiners will compare the pre treatment and post treatment images using the VAS scale. 1. Improvement in appearance 2. Changes in brown stains or Changes in opaque white areas 3. Requirements for further treatments And the data will be analyzed using statistical parameters |