| CTRI Number |
CTRI/2024/07/070473 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vitamin C in gingival depigmentation |
|
Scientific Title of Study
|
Comparative evaluation of ascorbic acid injections and topical gel application for management of gingival hypermelaninpigmentation patients. A randomized controlled 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. G K CHETANA |
| Designation |
Post Graduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T.Nagar Post, Bengaluru, 560032
Bangalore KARNATAKA 560032 India |
| Phone |
7026519371 |
| Fax |
|
| Email |
chetanagk15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Umesh Yadalam |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T.Nagar Post, Bengaluru , 560032
Bangalore KARNATAKA 560032 India |
| Phone |
9844269511 |
| Fax |
|
| Email |
umeshyadalam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. G K CHETANA |
| Designation |
Post Graduate student |
| Affiliation |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
| Address |
Sri Rajiv Gandhi College of Dental Sciences and Hospital, Cholanagar, R.T.Nagar Post, Bengaluru, 560032
Bangalore KARNATAKA 560032 India |
| Phone |
7026519371 |
| Fax |
|
| Email |
chetanagk15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Rajiv Gandhi College of Dental Sciences and Hospital,
cholanagar, R. T. Nagar post, Bengaluru, 560032 |
|
|
Primary Sponsor
|
| Name |
G K Chetana |
| Address |
#17, Tande Taayi, Santosh Vihar, 19th A Cross, opposite GKVK gate, Jakkur layout, Bengaluru, 560092 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 G K Chetana |
Sri Rajiv Gandhi College of Dental Sciences and Hospital |
Department of Periodontics, Room no.12, Cholanagar, R.T.Nagar Post, Bengaluru, 560032 Bangalore KARNATAKA |
7026519371
chetanagk15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethical Committee, Sri Rajiv Gandhi College of Dental Sciences |
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 |
| Comparator Agent |
Vitamin C gel |
Vitamin C topical gel application once daily at night for 3 months |
| Intervention |
Vitamin C Mesotherapy |
Vitamin C intramucosal injections to be injected locally for 3 times with 1 week interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with age group: 18 - 40 years, both males and females. Individuals with untreated melanin pigmentation in the anterior portion of the upper or lower gingiva. |
|
| ExclusionCriteria |
| Details |
Patients who had previous depigmentation procedures. Patients with known hypersensitivity to ascorbic acid, under medication, systemic diseases, non-vital anterior teeth, active caries
or who have undergone periodontal therapy in the past 6 months.
Pregnant and lactating women, smokers and tobacco users. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival pigmentation graded by the Dummett-Gupta Oral Pigmentation Index |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, satisfaction and cosmetic changes using Mc Gill pain and satisfactory questionnaire |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="6" 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
|
Though physiological gingival hyperpigmentation is not considered a pathological entity, it is considered a major issue in aesthetic dentistry. Gingival hyperpigmentation of the gingiva along the anterior teeth with considerable gingival exposure during smiling is an increasing cause of concern among young individuals. The most commonly pigmented intraoral tissue is the attached gingiva followed by the interdental papilla and alveolar mucosa. Gingival hyperpigmentation is attributed to the increased melanin deposition by the melanocytes within the basal and supra-basal layers of the oral epithelium physiologically. Etiological factors associated with increased gingival pigmentation are smoking, genetics, heavy metal poisoning, endocrine disorders, UV ray exposure, inflammation, benign and malignant conditions, drugs, and tattooing. Various techniques are used for the removal of gingival hyperpigmented areas such as conventional techniques using excision/scalpel method, gingival abrasion by diamond burs, electrosurgery, lasers, cryosurgery, radiosurgery, additive masking procedures using soft tissue grafts or acellular dermal matrix allograft (ADMA). Non-surgical approaches that used 90% phenol or 95% ethanol solutions for chemical de-epithelization were considered harmful to the oral tissues as they burn and slough the epithelial layer containing the melanocytes. Another minimally invasive non-surgical approach is the local administration of bioactive substances in small amounts to the concerned area known as mesotherapy. Ascorbic acid can be effectively delivered using mesotherapy as a minimalistic and fairly safe depigmenting approach. Ascorbic acid/Vitamin C downregulates dopaquinone (precursor during the formation of melanin) synthesis as it has a suppressing action on the activity of tyrosine. It also has an epigenetic inhibitory effect on the genes associated with the function of melanocytes. Few studies in the literature have reported the local application of ascorbic acid as an adjunct to surgical techniques in managing gingival pigmentation. As far, there very limited studies comparing the Vitamin C mesotherapy and topical gel application for gingival hyperpigmentation. Therefore, this study hypothesized to evaluate and compare the effect of Ascorbic acid mesotherapy as a topical gel in the treatment of gingival hyperpigmentation. |