| CTRI Number |
CTRI/2019/07/019984 [Registered on: 02/07/2019] Trial Registered Prospectively |
| Last Modified On: |
01/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Use of Different Lasers for Pigmented Gums |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of two different wavelength diode lasers for the management of gingival hyperpigmentation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha R Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute Medical Science |
| Address |
Department Of Periodontics Sharad Pawar Dental College Datta Meghe Institute Of Medical Science sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620420917 |
| Fax |
|
| Email |
dikshaagrawal81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Guide |
| Affiliation |
Datta Meghe Institute Medical Science |
| Address |
Department Of Periodontics Sharad Pawar Dental College Datta Meghe Institute Of Medical Science Sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha R Agrawal |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute Medical Science |
| Address |
Department Of Periodontics Sharad Pawar Dental College Datta Meghe Institute Of Medical Science sawangi Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620420917 |
| Fax |
|
| Email |
dikshaagrawal81@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Diksha R Agrawal |
| Address |
Department Of Periodontics Sharad Pawar Dental College Datta Meghe Institute Of Medical Science sawangi Wardha |
| Type of Sponsor |
Other [Sharad Pawar Dental College ( Datta Meghe Institute Of medical Science) Deemed University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Priyanka Jaiswal |
Sharad pawar dental college, Datta meghe institute of medical science, sawangi meghe, wardha |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Diksha R Agrawal |
Datta Meghe Institute of medical science |
Department of periodontics,Sharad pawar dental college, Datta meghe institute of medical science, sawangi meghe, wardha
Wardha
MAHARASHTRA |
7620420917
dikshaagrawal81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE DMIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingival melanin hyperpigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
diode laser |
1470 nm wavength |
| Comparator Agent |
diode laser |
980 nm wavelength |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Esthetic conscious,
Systemically healthy patients
|
|
| ExclusionCriteria |
| Details |
Habit history like smoking, tobacco chewing, Pigmentation linked to malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement Of Gingival Pigmentation |
One Month After Laser Therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes In Pigmentation Based On Dummet’s Oral Pigmentation Index, Pain Score Using Visual Analogue Scale (VAS), Excision Time
|
Six month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2019 |
| Date of Study Completion (India) |
01/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Lasers have been used as an effective, comfortable and reliable
technique for gingival depigmentation. This study compares the effect of two different wavelength diode laser for the management of gingival melanin hyperpigmentation . This study undertaken for aesthetic purpose and undertaken in India. |