| CTRI Number |
CTRI/2024/05/067411 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Scalpel and Microneedling in managament of Gingival depigmentation |
|
Scientific Title of Study
|
“Comparative Evaluation of Gingival Depigmentation By Scalpel And Microneedling With Ascorbic Acid†|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarna Meenakshi p |
| Designation |
Post Graduate Student |
| Affiliation |
saveetha dental college, SIMATS Universitychennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College and Hospital, No 162, Poonamalle high road, Velappanchavadi, Chennai-600077
Clinic 25, 4th floor,Department of Periodntics, Saveetha Dental College, No-162, Poonamalle High road, Velappanchavadi, Chennai-600077, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
09578983680 |
| Fax |
|
| Email |
swarnameenakshi1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarna Meenakshi p |
| Designation |
Post Graduate Student |
| Affiliation |
saveetha dental college, SIMATS University chennai |
| Address |
Clinic 25, 4th floor,Department of Periodntics, Saveetha Dental College, No-162, Poonamalle High road, Velappanchavadi, Chennai-600077, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
09578983680 |
| Fax |
|
| Email |
swarnameenakshi1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subasree S |
| Designation |
Senior Lecturer |
| Affiliation |
saveetha dental college, chennai |
| Address |
Clinic 25, 4th floor,Department of Periodntics, Saveetha Dental College, No-162, Poonamalle High road, Velappanchavadi, Chennai-600077, Tamil Nadu
Chennai
TAMIL NADU
600077
India |
| Phone |
09710632868 |
| Fax |
|
| Email |
subasrees.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College, Saveetha Institute of Medical and technical sciences, Saveetha University, no 162, poonamalle high road, Velappanchavadi, Chennai-600077. |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college and hospital SIMATS University |
| Address |
Clinic 25, 4th floor,Department of Periodontics, Saveetha Dental College, No-162, Poonamalle High road, Velappanchavadi, Chennai-600077, Tamil Nadu |
| 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 |
| swarna meenakshi |
Saveetha dental college, simats University, Chennai |
Clinic 25, 4th floor,Department of Periodntics, Saveetha Dental College, No-162, Poonamalle High road, Velappanchavadi, Chennai-600077, Tamil Nadu
Chennai
TAMIL NADU |
09578983680
swarnameenakshi1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling |
microneedling done with ascorbic acid |
| Comparator Agent |
Scalpel |
Gingival depigmentation is done with conventional technique scalpel |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18 and above; 2) demonstrated systemic health; and 3) exhibited physiologic gingival hyperpigmentation within the aesthetic zone |
|
| ExclusionCriteria |
| Details |
1) systemic disorders, particularly patients with bleeding disorders; 2) individuals undergoing chemotherapy; 3) pregnant women 4) smokers; and 5) gingivitis and periodontitis patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intensity of pigmentation |
baseline, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| wound healing |
1st day, 7th day |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
30/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2024 |
| 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)
|
Completed |
| 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
|
Background: Gingival pigmentation, characterized
by the presence of melanin in the gingival tissues, is a common aesthetic
concern in dental practice. While it poses no inherent health risks, the
visible discoloration may cause psychological distress for individuals seeking
optimal dental aesthetics. Understanding the efficacy of various methods is
essential for refining treatment strategies and enhancing patient satisfaction
in the realm of gingival depigmentation.
Aim: The objective of the study is to
compare the effectiveness of scalpel and microneedling with ascorbic acid in
the treatment of gingival depigmentation.
Materials
and Methods: Sixteen
patients who had a complaint of gingival pigmentation were included in the
study, out of which 8 patients were allocated for scalpel group and the other 8
patients were treated with microneedling technique with ascorbic acid.
Postoperative wound healing scores were evaluated at the 1st and 7th day
respectively. Intensity of depigmentation was assessed at baseline, 1st month
and at the end of 3rd month respectively.
Results: The mean DOPI score in the baseline
were 2.65±0.16 and 2.61± 0.17 in the surgical and MN with ascorbic acid groups
respectively. The mean DOPI score at the end of 3rd month was 1.67 ±0.39 and
0.87± 0.17 in the surgical and MN with ascorbic acid groups respectively. There
was a statistically significant difference between the scalpel and MN &
ascorbic acid groups at the end of 1st month and 3rd month respectively with MN
& ascorbic acid showing esthetically pleasing outcomes. Patients treated
with scalpel technique showed incomplete healing and ulceration on 1st and 7th
day after the procedure when compared to the microneedling technique with
ascorbic acid. Healing index scores were statistically significant in the MN
& ascorbic acid group.
Conclusion: Microneedling technique with
ascorbic acid is a successful technique in treating gingival depigmentation. It
showed esthetically gratifying outcomes when compared to the conventional
surgical technique. |