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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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