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临床试验/CTRI/2024/07/070473
CTRI/2024/07/070473尚未招募Phase 3 4

Comparative evaluation of ascorbic acid injections and topical gel application for management of gingival hypermelaninpigmentation patients. A randomized controlled study

G K Chetana1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Gingival pigmentation graded by the Dummett-Gupta Oral Pigmentation Index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Subjects with age group:
  • 40 years, both males and females. Individuals with untreated melanin pigmentation in the anterior portion of the upper or lower gingiva.

排除标准

  • 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.

结局指标

主要结局

Gingival pigmentation graded by the Dummett-Gupta Oral Pigmentation Index

时间窗: Baseline, 3 months

次要结局

  • Pain, satisfaction and cosmetic changes using Mc Gill pain and satisfactory questionnaire(Baseline and 3 months)

研究者

发起方
G K Chetana
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

Dr. G K CHETANA

Sri Rajiv Gandhi College of Dental Sciences and Hospital

研究点 (1)

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