| CTRI Number |
CTRI/2024/05/067185 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Hyaluronic Acid Gel and Vitamin E for Healing After Gum Laser Treatment: A clinical study |
|
Scientific Title of Study
|
Comparative Evaluation Of Effectiveness Of Hyaluronic Acid Gel And Vitamin E Application On Healing After Laser Gingival Depigmentation– A Randomized Clinical Trial |
| 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 Samiksha Ashok Mandavkar |
| Designation |
Post Graduate Student |
| Affiliation |
YMT Dental College and Hospital |
| Address |
Department No. 3, Department of Periodontics, Y M T Dental College and Hospital, institutional Area 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
400610
India |
| Phone |
09619988162 |
| Fax |
|
| Email |
mandavkarsam97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rizwan Sanadi |
| Designation |
Guide & Professor |
| Affiliation |
YMT Dental College and Hospital |
| Address |
Department No. 3, Department of Periodontics, Y M T Dental College and Hospital, institutional Area 4, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
400610
India |
| Phone |
9730858235 |
| Fax |
|
| Email |
drriz28@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samiksha Ashok Mandavkar |
| Designation |
Post Graduate Student |
| Affiliation |
YMT Dental College and Hospital |
| Address |
Department No. 3, Department of Periodontics, Y M T Dental College and Hospital, institutional Area 4, Kharghar, Navi Mumbai
Thane
MAHARASHTRA
400610
India |
| Phone |
09619988162 |
| Fax |
|
| Email |
mandavkarsam97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol Foundation Y M T Dental College and Hospital, Institutional Area, Sector- 4, Kharghar, Navi Mumbai, India, 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Samiksha Mandavkar |
| Address |
A- 402, Prabhat Upvan CHS LTD, Pokhran Road No. 2, Gawand Bagh, Thane (W), 400610 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ELAF MEDICAL SUPPLIES |
AL MADENA AL MONAWARA STREET RANA CENTRE, BUILDING NO 263, JORDEN |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rizwan Sanadi |
YMT Dental College and Hospital |
Department No.3, Department of Periodontics, Y M T Dental College and Hospital, Institution Aera, Sector 4 , kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9730858235
drriz28@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Y.M.T. Dental college and Hospital Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic Acid Gel(Hyadent BG) |
1,6% cross linked hyaluronic acid gel, Applied topically twice daily post-surgery on a surgical area for up to 1 week |
| Comparator Agent |
vitamin E (Evion capsules) |
400mg vitamin E capsules, break the capsule and application of vitamin E gel on surgical area for up to 1 week, twice daily |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy cooperative subjects
Age group of 15-45 years of either sex
Presence of bilateral gingival melanin hyperpigmentation (DOPI Index score 2 or greater than 2)
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hyaluronic acid gel application versus Vitamin E application after laser gingival depigmentation have any beneficial effect on
a) Wound healing
b) Degree of post-operative pain
c) Discomfort experienced by patients
|
All the clinical parameters will be assessed at 1 week, 2 weeks, 1 month and 3 months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hyaluronic acid gel application versus vitamin E application after laser gingival depigmentation result in Reduction in gingival inflammation
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a randomised, single blinded study. In today’s era, facial cosmetic concerns as well as
increase intraoral awareness have created a demand for aesthetics in periodontal
practice. Clinical melanin pigmentation is benign and is not a medical problem,
but pigmented gingiva may be a cause of aesthetic concern particularly in
patients with high smile line or gummy smile. Laser ablation has
been recognised recently as the most effective, pleasant, and reliable
technique. It has advantage of easy handling, short treatment time,
haemostasis, decontamination, and sterilization effect. However, till date no study has been conducted where in
healing effects of HA is compared with Vitamin E after laser gingival
depigmentation. Hence, the present study will be undertaken.
In this study, a total of 24 individuals with 48
sites having gingival hyperpigmentation will be recruited. The sites will be
divided by simple randomization technique as,Site A- Site will be treated with HA and Site B- Site will be treated with Vitamin
E.Patients will be recalled after 1week, 2week, 4week and 3months
post-operatively and all the parameters will be evaluated. |