| CTRI Number |
CTRI/2024/06/068345 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of Diode LASER and Microneedling in the treatment of dark gums |
|
Scientific Title of Study
|
Comparative Evaluation of Diode LASER and Microneedling in the assessment of Gingival Melanin Hyperpigmentation-A clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srashti Mangal |
| Designation |
PG student |
| Affiliation |
Bharati vidyapeeth dental college and hospital |
| Address |
Room no 3, Department of periodontology, Bharati Vidyapeeth deemed to be university dental college and hospital pune
Pune
MAHARASHTRA
411046
India |
| Phone |
7772048471 |
| Fax |
|
| Email |
srashtimangal1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Lele |
| Designation |
Assistant professor |
| Affiliation |
Bharati vidyapeeth dental college and hospital |
| Address |
Room no 3, dept of periodontology, Bharati vidyapeeth deemed to be university dental college and hospital
Pune
MAHARASHTRA
411046
India |
| Phone |
9561095831 |
| Fax |
|
| Email |
priya.lele@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srashti Mangal |
| Designation |
PG student |
| Affiliation |
Bharati vidyapeeth dental college and hospital |
| Address |
Room no 3, dept of periodontology, Bharati vidyapeeth deemed to be university dental college and hospital
Pune
MAHARASHTRA
411046
India |
| Phone |
7772048471 |
| Fax |
|
| Email |
srashtimangal1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth(Deemed to be university) dental college and hospital, satara road Pune (Maharashtra) India
Pin-411043 |
|
|
Primary Sponsor
|
| Name |
Bharati vidyapeeth dental college and hospital |
| Address |
Bharati Vidyapeeth( Deemed to be university) Dental College and Hospital,Pune Maharashtra India
pin code-411043 |
| 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 Srashti Mangal |
Bharati Vidyapeeth(Deemed to be university) Dental college and hospital Pune pin code-411043 |
Room no 3, department of periodontology
Pune
MAHARASHTRA |
7772048471
srashtimangal1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LASER device |
Novolase Diode laser with 300micrometer diameter at 2.5 W power, 810 nm wavelength in contact mode will be used |
| Comparator Agent |
Microneedling pen |
Derma Pen with 12 needle cartridge will be used till bleeding points are seen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy subjects who had moderate to severe melanin pigmentation and who are conscious about their esthetics |
|
| ExclusionCriteria |
| Details |
subjects who are smokers, pregnant and lactating women, subjects with debilitating diseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| micro needling is a cost-efficient painless minimally invasive method for depigmentation |
Baseline and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This will help to ease patient comfort and improve esthetics among population |
Day1, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 2 |
|
Date of First Enrollment (India)
|
14/06/2024 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we will be comparing diode laser and microneedling in the treatment of gingival hyperpigmentation. After local infiltration both the techniques will be carried out in different patients at baseline and 14 th day and then results will be evaluated accordingly. The purpose of this study is that although lasers have been proved to be a goof treatment modality but the cost is high and the armamentarium needed is more and the laser safety protocol are to be foolowed during the procedure so to avoid all this problems microneedling is carried out as it is nowadays very common in cosmetic dermatology. It is minimally invasive and cost efficient procedure. |