| CTRI Number |
CTRI/2024/07/070297 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing microneedling procedure with vitamin-c and electrosurgery for the treatment of black gums |
|
Scientific Title of Study
|
Evaluation of gingival depigmentation using microneedling procedure with vitamin-c and electrosurgery: A split mouth randomized controlled 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 Souparnika M Kulkarni |
| Designation |
PG student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8050512662 |
| Fax |
|
| Email |
kullkarnisouparnika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
|
|
Primary Sponsor
|
| Name |
Dr Souparnika M Kulkarni |
| Address |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327 |
| Type of Sponsor |
Other [Self] |
|
|
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 Souparnika M Kulkarni |
KVG Dental College and Hospital |
Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India
Pincode 574327
Dakshina Kannada
KARNATAKA |
8050512662
kullkarnisouparnika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electrosurgery |
Electrosurge ART-E1 Electrosurgical unit is used to remove the hyperpigmented gingival epithelium in maxillary or mandibular anterior region using loop electrode. The duration of procedure will be 15 minutes. |
| Intervention |
Microneedling and Vitamin c |
Dermapen is a Microneedling instrument that is Dr Pen automironeedle system Ultima M8 is used.The instrument has 6 frequency of speed modes. The instrument is placed at right angle to the gingival surface and procedure will be performed in maxillary or mandibular anterior region.
Vitamin c 100%L-Ascorbic acid is used,1g of Vitamin c will be mixed with 2-3 drops of saline make a paste and apply topically to the gingival mucosa for 10 minutes. Leave the area without dressing. The duration of the procedure will be 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients with age group between 18-50 years with no previous treatment
that affect the gingival health or color.
Subjects with mild to severe gingival pigmentation. (DOPI: Dummet and oral
pigmentation index).
Subjects with good oral hygiene. |
|
| ExclusionCriteria |
| Details |
Tobacco chewers and smokers.
Fully edentulous patients.
Patients who have any underlying systemic disease that induces the production of melanin.
Pregnant and lactating women.
Patient who are taking medications that influence the gingival color such as minocycline,
zidovudine
Patients allergic to vitamin-c
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficiency of microneedling procedure with vitamin-c and electrosurgery for
treating gingival pigmentation. |
6month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the intensity & extension of pigmentation, bleeding, wound healing, post-operative
pain & recurrence following gingival depigmentation using microneedling procedure with
vitamin-c.
To evaluate the intensity & extension of pigmentation, bleeding, wound healing, postoperative pain & recurrence following gingival depigmentation using electrosurgery. |
7days,15days,1month,6month |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="0"
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
|
The gingiva is a part of oral mucosa that covers the alveolar process of the jaws and surrounds the neck of the tooth.The color of healthy gingiva is coral pink. Gingival color changes due to the degree of keratinization ,vascularity, gingival epithelial thickness and pigmentation. Gingival pigmentation is maybe due to physiological or pathological factor which causes increased formation of melanin granules in melanocytes. Other causes for hyperpigmentation are genetics, drugs, and metals like bismuth, arsenic, mercury and lead. Lead pigmentation is due to perivascular precipitation of metallic sulfides in subepithelial connective tissue, endocrine disorders like Peutz-Jeghers syndrome and habits (smoking).Gingival pigmentation is more commonly seen in females than males. Dark skinned individuals will be having more melanin production in their body. Gingival depigmentation is a periodontal plastic procedure where removal of the epithelium layer along with connective tissue so that new gingival epithelium regenerates. Treatment options for gingival hyperpigmentation may be divided into two groups: techniques to eliminate the pigments and hide the pigments. Pigment elimination can be done surgically, non-surgically, or chemically. Scalpel surgery, laser ablation, cryosurgery, bur abrasion electrocautery, and radiosurgery are some of the most common surgical techniques. Chemical cauterization is the most common non-surgical method. Use of free gingival autograft operations and the acellular dermal matrix allograft are examples of masking gingival colors. Microneedling a novel non surgical procedure that necessitates puncturing the skin with sterilized microneedles on a regular basis. The needles pierce the skin and generate very tiny pores known as micro-conduits, these micro-injuries cause minor surface bleeding and initiation of a wound-healing pathway that includes inflammation, proliferation, and remodeling. Vitamin C is a water-soluble antioxidant referred to as ascorbic acid, is vital to the growth of strong bones, teeth, gums, ligaments, and blood vessels and is involved in important functions.Also, the anti-pigmentation properties of vitamin C are evident. It interacts with copper and inhibits the tyrosinase enzyme’s action, thus decreasing melanin formation. There are many articles providing various comparative studies with electrosurgery, but the comparison of different techniques with microneedling has not been done as per our knowledge. The rationale behind the study is to compare the efficacy of microneedling procedure with vitamin-c and electrosurgery for treating gingival pigmentation. |