| CTRI Number |
CTRI/2024/05/066602 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Microneedling with vitamin C application for the treatment of gum melanin hyperpigmentation |
|
Scientific Title of Study
|
Microneedling with Topical Vitamin C versus Scalpel Technique for the Esthetic Management of Physiologic Gingival Melanin Hyperpigmentation: A Randomized Controlled 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 Anika Dawar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room no 511, 5th floor, Division of Periodontics Centre for Dental Education,All India Institute of Medical Sciences, Ansari Nagar, New Delhi
110029
New Delhi DELHI 110029 India |
| Phone |
9953270897 |
| Fax |
|
| Email |
anika_doc@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anika Dawar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room No. 511, 5th floor,Division of Periodontics, Centre for Dental Education,AIIMS, Ansari Nagar, New Delhi
110029
New Delhi DELHI 110029 India |
| Phone |
9953270897 |
| Fax |
|
| Email |
anika_doc@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anika Dawar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of medical Sciences, New Delhi |
| Address |
Room no 511, 5th floor,Division of Periodontics, Centre for Dental Education,AIIMS, Ansari Nagar, New Delhi
110029
New Delhi DELHI 110029 India |
| Phone |
9953270897 |
| Fax |
|
| Email |
anika_doc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Centre for Dental Education and Research, All India institute of Medical Sciences, Ansari Nagar,New Delhi,India 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Anika Dawar |
| Address |
Division of Periodontics, Centre for dental Education and Research, All India Institute of Medical Sciences, New Delhi,India 110029 |
| Type of Sponsor |
Other [Self-sponsered] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anika Dawar |
Centre for Dental Education and Research |
Division of Periodontics, 5th floor, Centre for Dental Education and Research, All India institute of Medical Sciences,Ansari Nagar, New Delhi South DELHI |
9953270897
anika_doc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences,New Delhi |
Approved |
|
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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 |
Microneedling with topical vitamin C |
Dermapen device(Model M8) with 16 pins stainless steel needle cartridge attachment, will be used for microneedling pigmented gingiva. The depth of the penetration of needles will be adjusted from 0.25mm to 1.5 mm based on the gingival tissue thickness. Dermapen will be applied intermittently in a stamp-like motion on the gingiva for 30-40 seconds /tooth, covering the entire anterior pigmented area, until multiple bleeding points appear. The area will be irrigated with saline solution and will be dried with gauge. Vitamin C (1000mg/5ml ampoule containing L-ascorbic acid) will be dispensed from the ampoule in a sterile steel bowl and will be applied on pigmented gingiva with a cotton roll in a circular motion. Subsequently, completely soaked cotton with vitamin C will be left on the entire target area for 10 minutes. The same process will be repeated for 4 sessions, with 1 week interval in between. |
| Comparator Agent |
Surgical scalpel technique |
After local anaesthesia administration,using a 15 No. blade partial thickness incision will be given on the keratinized gingival surface , with the blade parallel to long axis of the tooth to remove hyperpigmented epithelial layer and a part of underlying connective tissue. Remaining tissue tags will be removed using microsurgical scissors or tissue nippers to ensure all pigment is removed. Surgical site will be irrigated and haemostasis will be achieved with a pressure gauze pack. The site will be covered with a periodontal pack, to protect the surgical site till healing occurs. Post-operative instructions will be given. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Physiologic gingival hyperpigmentation as diagnosed by recent classification of Periodontal and Peri-implant diseases 2017
2.Physiologic gingival hyperpigmentation in anterior aesthetic zone of maxillary gingiva
3. Adults seeking gingival depigmentation treatment for esthetic concerns.
4. Available/Willing to come for 4 subsequent visits and follow-ups
5.Adequate oral hygiene
6.No systemic illness
|
|
| ExclusionCriteria |
| Details |
1. Pathologic or drug-induced gingival pigmentation
2. Physiologic gingival pigmentation only in mandibular gingiva
3. Any systemic disease causing gingival hyperpigmentation
4. Smokers
5. Pregnant or lactating females
6. Patients with periodontal disease
7. Patients taking vitamin C supplements
7. Patients with hypersensitivity to ascorbic acid
8.Patient taking vitamin C supplements
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in gingival pigmentation intensity score( Dummett- Gupta oral pigmentation index)
0: no clinical pigmentation(pink tissue),1: mild clinical pigmentation(mild light brown color), 2:moderate clinical pigmentation (medium brown or mixed pink and brown coloration,3: heavy clinical pigmentation(deep brown or blue-black tissue). |
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in gingival pigmentation extent score( Gingival pigmentation index)
0: Absence,1: spots of brown or black, 2: brown or black patches but not diffuse,3: diffuse brown or black pigmentation |
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
Change in Gingival thickness
|
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
Change in Gingival pigmented area on digital photographs
|
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
Change in Gingival Luminescence(L value: 0 to 100) on digital photographs
|
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
| Difference in patient reported Pain, Itching, Discomfort VAS scores |
From the day of procedure upto 7 days |
| Difference in patient reported color improvement and overall treatment satisfaction scores |
Follow-up visits at 1,3,6 months after completion of treatment |
| Change in gingival melanin score(0-100) |
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
| Correlation of change in gingival melanin score with skin melanin score |
Baseline and follow-up visits at 1,3,6 months after completion of treatment |
|
|
Target Sample Size
|
Total Sample Size="26" Sample Size from India="26"
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 4 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Gingival hyperpigmentation is a darker gingival color than what is normally expected. The hyperpigmentation caused sure to an "increased production and release of the melanin by melanocytes in the basal and supra-basal layer is called "Gingival Melanosis". Physiological gingival melanosis/hyperpigmentation is not a pathological condition, but "black gums" represents an aesthetic concern for many patients. Gingival depigmentation is a periodontal plastic procedure to reduce or remove hyperpigmentation from the gingivaConventional methods commonly used, involve mechanical de-epithelization of pigmented gingiva and some underlying connective tissue with a scalpel, LASERS, electrocautery, bur, to obtain a regenerated epithelium free of melanin. Surgical stripping with scalpel, is the most time-tested, inexpensive technique and is considered gold standard for gingival depigmentation. However, is associated with disadvantages like fear, post-operative pain, bleeding, discomfort and interference in normal activities of chewing, smiling etc. and higher rates of regimentation. Moreover, it is challenging to perform any of the surgical methods in cases of thin gingival biotype as it can sometimes lead to gingival recession and/or bone exposure. Therefore, there is a need to explore other minimally invasive non-surgical, simple, inexpensive therapeutic options as an alternative for the esthetic management of physiologic gingival hyperpigmentation. Amongst the non-surgical approaches, vitamin C (ascorbic acid) has recently been explored for gingival hyperpigmentation. Vitamin C interferes with the steps of melanogenesis and causes depigmentation of tissues. Vitamin C offers additional advantages of having anti-inflammatory, antioxidant properties and promotion of collagen synthesis, making it a suitable therapeutic agent for both for skin and gingival health. Topical form though easier and painless to apply, has a poor availability due to salivary washout effect in oral cavity, and thus a weak depigmentation action. Injectable vitamin C (Intraepidermal oral mesotherapy),involves the introduction of vitamin C into superficial layers of the oral tissue extending between basement membrane into superficial connective tissue using fine needles. Vitamin C mesotherapy has shown good patient outcomes due to psychological comfort of using non-surgical procedure, being cheap and minimally invasive, involving shorter appointments, and no interference with the normal oral functions .However, the drawback of injectable vitamin C is that penetration depth cannot be controlled. Although vitamin C is safe, it is a weak acidic product which can result in increased itching or tissue necrosis if given in higher dose or with a deeper penetration. Another consideration is product leak out from areas of canine eminence, mucogingival junction, and areas of very thin tissue biotype, thus tactile sensation is quite important. Hence, further exploration in this area is warranted to improve the delivery of vitamin C in gingiva to achieve better clinical and patient-reported outcomes. In this context, use of microneeedling technique for gingival pigmentation can be explored, similar to its use in Dermatology. Microneedling as a standalone treatment or in combination with local therapeutics like vitamin C has gained popularity in recent years for managing skin hyperpigmentation’s like Melasma. Microneedling is a technique of repeated punctures by micronâ€sized needles (height ranging from 0.025 to 2mm) that breach the outermost layer of the epithelium (stratum corneum) and creates tiny pores known as micro-conduits. In Dentistry, the use of microneedling is very recent with scarce literature. A recent study has used microneedling with dermapen as a minimally invasive standalone treatment for gingival depigmentation with encouraging results. Exploring microneedling in combination with topical vitamin C can be advantageous as it can offer synergistic effects of depigmentation and collagen induction action of microneedling process together with improved delivery of vitamin C, a potent depigmentation and collagen promotion agent; through microchannels created. The dual benefit of depigmentation together with improvement of gingival thickness, could be advantageous in cases of thin gingival biotype, where performing surgical depigmentation technique is challenging. Currently, there is a paucity of studies comparing surgical and non-surgical gingival depigmentation techniques, with no definite guidelines. The present randomized trial aims to compare the clinical and patient-reported outcomes of gingival depigmentation using non-surgical technique of microneedling (with Dermapen) with topically applied vitamin C versus conventional surgical scalpel technique.
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