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临床试验/CTRI/2024/07/070366
CTRI/2024/07/070366尚未招募不适用

Efficacy of Superoxidised solution and Povidone iodine solution with periodontal dressing in gingival depigmentation A split mouth randomized controlled trial

Dr Impana H A1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
1.To compare the efficacy of Superoxidised solution and Povidone iodine solution in gingival depigmentation by evaluating the degree of pigmentation using Dummett oral pigmentation index in the treated areas.

研究概览

简要总结

Gingival pigmentation is presented as a diffuse deep purplish discolouration or as irregularly shaped brown or black patches, striae or strands. Melanin, carotene, reduced haemoglobin and oxy-haemoglobin are the prime pigments contributing to the normal colour of the gingiva . Excessive deposition of melanin located in the basal and suprabasal cell layers of the epithelium will result in gingival hyperpigmentation(Dummett,1979). Gingival hyperpigmentation is an aesthetic concern. It can be physiological or pathological. Physiological hyperpigmentation is genetic and does not pose any health concerns, whereas pathological hyperpigmentation is a health concern and can occur due to variety of reasons like endocrine disorders, ingestion of heavy metals, Kaposi’s sarcoma, smoking, etc . Gingival depigmentation can be defined as a periodontal plastic surgical procedure whereby the gingival hyperpigmentation is removed or reduced by various techniques .A variety of depigmentation techniques have been described in the literature which can be classified as surgical and non surgical or chemical methods. Surgical methods mainly include bur abrasion, scalpel surgery, electrocautery, laser ablation, cryosurgery, radiosurgery, gingivectomy. Nonsurgical methods mainly refer to chemical cauterization using alcohols, phenols, ascorbic acid . A scalpel technique is one of the first techniques employed for gingival melanin depigmentation that involves surgical removal of gingival epithelium along with a layer of underlying connective tissue, thus allowing the denuded connective tissue to heal by secondary intention . It is traditional approach which is simple, easy to perform, cost effective, with minimum discomfort and aesthetically acceptable to patient. Superoxidised solution and Povidone Iodine solution represent two distinct interventions for gingival depigmentation, each with its unique characteristics and purported advantages. It is crucial to understand the comparative effectiveness of Superoxidised solution alongside Povidone iodine solution, a more traditional approach, to provide practitioners with a comprehensive understanding of available options. Superoxidised solution , a relatively novel method, is gaining attention for its ease of application and potential efficacy.The importance of Superoxidised solution lies in its potential to offer a less invasive and more patient friendly adjunct for gingival depigmentation. The spray form allows for precise application, potentially reducing discomfort during the procedure, as it is superoxidised solution which is colourless solution, has an anti inflammatory effect , it has bactericidal, fungicidal, sporicidal properties ,reduces patient discomfort, helps in early healing of the wounds . Understanding its efficacy compared to Povidone iodine solution is pivotal for practitioners seeking to incorporate innovative and patient-centric methods into their cosmetic dentistry practices. On the other hand, Povidone Iodine solution has been a longstanding choice for depigmentation, known for its effectiveness, which acts as a disinfectant , used as an oxidizing agent ,has an antimicrobial action. However, the comparative assessment with Superoxidised solution is essential to validate its continued relevance and identify potential areas for improvement .This study is essential as it aims to fill the existing gap in the literature by directly comparing the two treatments in a controlled manner, employing a split-mouth technique. Such a design enhances the internal validity of the study, minimizing the impact of confounding variables. The comparison of Superoxidised solution and Povidone iodine solution is specifically chosen to provide practitioners with evidence-based insights when deciding on the most suitable method for gingival depigmentation, as well as patient comfort and postoperative outcomes. While various methods exist for depigmentation, there is a scarcity of comprehensive comparative studies addressing the effectiveness and postoperative aspects of Superoxidised solution and Povidone iodine solution. Henceforth this study aims to evaluate and compare the effectiveness of Superoxidised solution and Povidone iodine solution with periodontal dressing in gingival depigmentation using a split -mouth technique.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

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 melanin hyperpigmentation of the upper and lower gingivae and good oral hygiene Subjects with aesthetic concerns Subjects who have the ability to understand and accept the requirements of the study.

排除标准

  • Subjects with thin gingival biotype.
  • Subjects who have the habit of smoking.
  • Subjects from the control group who have initiated the habit of tobacco smoking or chewing during the course of the study.
  • Subjects having medical conditions that compromised tissue healing (osteoporosis,hemophilia, anemia, etc.).
  • Subjects undergoing treatment with an interfering medication (bisphosphonate or steroid therapy).
  • Subjects who undergone radiation therapy within the last 2 years.
  • Subjects who have undergone any invasive periodontal therapy in the previous six months.
  • Unable or not willing to comply with the study protocol.

结局指标

主要结局

1.To compare the efficacy of Superoxidised solution and Povidone iodine solution in gingival depigmentation by evaluating the degree of pigmentation using Dummett oral pigmentation index in the treated areas.

时间窗: 1,3,5 days,1 week, 1month and 6 months

2.To assess patient discomfort associated with Superoxidised solution and Povidone iodine solution during and after depigmentation procedure.

时间窗: 1,3,5 days,1 week, 1month and 6 months

次要结局

  • To investigate and compare postoperative healing patterns including inflammation, pain, overall recovery, following the use of Superoxidised solution and Povidone iodine solution.(1,3,5 days,1 week, 1month and 6 months)

研究者

发起方
Dr Impana H A
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Impana H A

KVG Dental College and Hospital

研究点 (1)

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