| CTRI Number |
CTRI/2025/08/092428 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the healing after gingival depigmentation by using recombinant epidermal growth factor gel and oxygen releasing gel. |
|
Scientific Title of Study
|
Clinical and histological assessment and comparison of healing after gingival depigmentation following application of recombinant epidermal growth factor gel and oxygen releasing gel.
|
| 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 Shweta Gupta |
| Designation |
Post Graduate Student |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9793685360 |
| Fax |
|
| Email |
shwetathecool6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narender |
| Designation |
Reader |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
7011187632 |
| Fax |
|
| Email |
drnarenderidst@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor and HOD |
| Affiliation |
Institute of Dental Studies and Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar Ghaziabad
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Institute of Dental Studies and Technologies, NH-58,Delhi-Meerut Road, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH 201201 India |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies and Technologies |
| Address |
Room no 7,Department of Periodontics, NH-58, Delhi-Meerut Road,Kadrabad, Modinagar, Uttar Pradesh, India-201201 |
| 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 Shweta Gupta |
Institute of Dental Studies and Technologies |
Department of
Periodontology, Room
number 7 Institute of
Dental Studies and
Technologies
Ghaziabad
UTTAR PRADESH |
9793685360
shwetathecool6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Institute of Dental Studies & Technologies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Moderate to severe melanin pigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
blue m® gel |
blue m® gel is a oxygen
releasing gel which is based on the active oxygen and
lactoferrin both powerful
ingredients with a synergistic effect. It contains Aqua, Alcohol, Glycerin, Silica, Sodium Saccharin, Sodium Perborate, Citric Acid,PEG-32, Sodium Gluconate, Lactoferrin, Xanthan Gum, Cellulose Gum. It will be evaluated for 90 days.
|
| Intervention |
REGEN-D® 60 gel |
REGEN-D® 60 gel is a new generation therapy with an innovative treatment for first- and second-degree burns, bed sores and skin graft. It is thought to have a major impact on epidermal growth and differentiation, as well as on the natural healing process, which results in fewer scars and better healing. It will be evaluated for 90 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically and periodontally healthy patients.
2)Patients with well maintained oral hygiene.
3)Patients with aesthetic concerns having moderate to severe(score 2 or 3) gingival pigmentation of maxillary or mandibular anterior gingiva based on Dumett Gupta (1964). |
|
| ExclusionCriteria |
| Details |
1) Patients with thin gingival biotype.
2) Patients with missing anterior teeth.
3) Patients who are current or former smokers.
4) Pregnant and lactating females.
5) Non-compliant patients.
6) Patients with any metallic restoration or undergoing orthodontic therapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dumett Gupta Index score
Healing Index (Landry et al)
Visual Analogue Scale scores
Epithelization test (Toluidine Blue and Hydrogen
peroxide)
|
Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study was conducted by Dr. Shweta Gupta, Dr. Narender, Dr. Manish Khatri, Dr. Mansi Bansal, Dr Pratiksha Tripathi at Department Of Periodontology, Institute of Dental Studies & Technologies, Modinagar, Uttar Pradesh, India The purpose of this study is to clinically evaluate and histologically assess and compare the healing after gingival depigmentation following application of recombinant epidermal growth factor gel and oxygen releasing gel.
|