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临床试验/CTRI/2024/05/066602
CTRI/2024/05/066602进行中(未招募)4 期

Microneedling with Topical Vitamin C versus Scalpel Technique for the Esthetic Management of Physiologic Gingival Melanin Hyperpigmentation: A Randomized Controlled Clinical Trial

Dr Anika Dawar1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
26
试验地点
1
主要终点
Change in gingival pigmentation intensity score( Dummett- Gupta oral pigmentation index)

研究概览

简要总结

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 methodscommonly used, involvemechanical de-epithelization of pigmented gingivaand 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 disadvantageslike 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 theintroduction 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 micron‐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 recentwith 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • 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
  • Adults seeking gingival depigmentation treatment for esthetic concerns.
  • Available/Willing to come for 4 subsequent visits and follow-ups 5.Adequate oral hygiene 6.No systemic illness.

排除标准

  • Pathologic or drug-induced gingival pigmentation
  • Physiologic gingival pigmentation only in mandibular gingiva
  • Any systemic disease causing gingival hyperpigmentation
  • Pregnant or lactating females
  • Patients with periodontal disease
  • Patients taking vitamin C supplements
  • Patients with hypersensitivity to ascorbic acid 8.Patient taking vitamin C supplements.

结局指标

主要结局

Change in gingival pigmentation intensity score( Dummett- Gupta oral pigmentation index)

时间窗: Baseline and follow-up visits at 1,3,6 months after completion of treatment

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).

时间窗: Baseline and follow-up visits at 1,3,6 months after completion of treatment

次要结局

  • 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)
  • Change in Gingival thickness
  • Change in Gingival pigmented area on digital photographs
  • Change in Gingival Luminescence(L value: 0 to 100) on digital photographs
  • 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)

研究者

发起方
Dr Anika Dawar
申办方类型
Other [self-sponsered]
责任方
Principal Investigator
主要研究者

Dr Anika Dawar

All India Institute of medical Sciences, New Delhi

研究点 (1)

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