Comparative evaluation of ascorbic acid injections and topical gel application for management of gingival hypermelaninpigmentation patients. A randomized controlled study
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
Dr. G K CHETANA
Sri Rajiv Gandhi College of Dental Sciences and Hospital
