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临床试验/CTRI/2025/10/095567
CTRI/2025/10/095567尚未招募2 期

Evaluation of effectiveness of gum paint containing emlica officinalis and melatonin in patients with Gingivitis.- A Randomised Controlled Trial

Self1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
Self
入组人数
42
试验地点
1
主要终点
To evaluate and Compare Gum Paint Containing Emblica Officinalis and Melatonin in patients with Gingivitis

研究概览

简要总结

Gingivitis is a common and mild form of periodontal disease characterized by inflammation of the gingiva, the part of the gum that surrounds the base of the teeth. It is most often caused by poor oral hygiene, which leads to the accumulation of dental plaque, a sticky biofilm composed of bacteria on the tooth and gums. If not removed through regular brushing and flossing, this plaque hardens into tartar, further irritating the gums and triggering an inflammatory response. Clinically, gingivitis presents with symptoms such as redness, swelling, tenderness of the gums, and bleeding during brushing and flossing. Long-term studies have shown that persistent gingival inflammation significantly increases the risk of attachment loss and tooth loss. Preventive strategies such as routine oral hygiene, regular dental check-ups, and patient education are essential for its management and for preventing its progression to more serious periodontal diseases.

Amalaki, commonly known as amla or Indian gooseberry, is a highly valued herb in traditional Ayurvedic medicine and has been used for centuries for its wide range of therapeutic benefits. In oral health, amla has shown significant promise due to its astringent and antimicrobial properties. It helps tighten the gums, reduce bleeding, and combat infections, making it a valuable component in gum paint formulations.

Melatonin (N-acetyl-5-methoxytryptamine) has shown promising therapeutic potential in oral health. Its antioxidant properties allow it to neutralize reactive oxygen species (ROS), which are commonly elevated in inflammatory conditions like gingivitis and periodontitis. In dental applications, melatonin plays a role in enhancing osseointegration of dental implants, accelerating wound healing after extractions, and mitigating the cytotoxic effects of dental materials.

Gum paints available in the market and commonly used in gingivitis treatment for their antimicrobial properties are often synthetically prepared and may cause side effects such as skin irritation, dryness, and allergic reactions. These drawbacks highlight the need for safer alternatives.

In response, this study explores a novel gum paint formulation using melatonin and amla, natural agents known for their antioxidant, antiseptic, and antibacterial properties.

So the aim of the study is toevaluate the effectiveness of gum paint containing Emblica officinalis and melatonin in patients with gingivitis.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Subjects in the age range from 15 to 45 years
  • Those who have gingivitis having PPD greater than 4 mm.

排除标准

  • Patients who have undergone any periodontal therapy in the past 6 months
  • Patients with systemic diseases
  • History of any medication including antibiotic treatment within the previous 3 months or regular use of specific drugs known to affect periodontal tissues
  • Pregnant women and lactating mothers.

结局指标

主要结局

To evaluate and Compare Gum Paint Containing Emblica Officinalis and Melatonin in patients with Gingivitis

时间窗: At baseline and 21 days

次要结局

未报告次要终点

研究者

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

DR SUREKHA RATHOD

DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY. RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR.

研究点 (1)

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