跳至主要内容
临床试验/CTRI/2024/07/071649
CTRI/2024/07/071649招募中不适用

Comparison of Guava leaf extract gel versus Chlorhexidine gel in the treatment of Chronic Periodontitis.

Dr Siddhant Bhuyar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Plaque Index (PI), Gingival Index (GI), and

研究概览

简要总结

Chronic Periodontitis is multifactorial infectious disease in which chronic inflammation of periodontal apparatus leads to the destruction of surrounding periodontal tissue of teeth, which in turn cause loosening of teeth in their socket and eventually loss of teeth. Mainly, inflammation of periodontal tissue is caused by the Gram negative anaerobic bacteria which are Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, and Tannerella forsythia. An immuno- pathological response is triggered inside the periodontal tissue by the entry of these bacteria and their toxins, which activates inflammatory cells such as lymphocytes and macrophages, which then release cytokines and other bioactive chemicals. According to a study done by the WHO in 2018, around 15%–35% of adults are suffering from periodontal disease. Classical signs and symptoms of periodontal diseases are halitosis, bleeding gums while brushing and chewing, swollen and tender gingiva, mobility of teeth in their socket and recession of gingiva. There is a pressing need for improved diagnostic methods and affordable treatment approaches for periodontal disease. The goal of periodontal treatment is to cure the inflamed tissues, reduce the number of periodontal pathogens through mechanical debridement (scaling and root planning) with or without various surgical modalities and alter the host tissue response. Along with debridement therapy, use of chemotherapeutic agents are some of the other clinical methods employed to treat periodontal disease.

Psidium guajava Linn, commonly known as guava, has been used in ayurvedic medicine as a therapeutic agent. Guava is proven for its antidiarrheal, antimicrobial, antiparasitic, antitussive, hepatoprotective, antioxidant, antigenotoxic, antimutagenic, antiallergic, anticancer, and anti-hyperglycemic effects and also a good source of vitamin C. The leaves of guava have been reported to be used for the maintenance of oral hygiene according to Sharma et al 2021. The flavonoid compounds and their derivatives can inhibit the growth of different bacteria by disruption of membrane and inactivation of extracellular proteins by forming irreversible complexes. The adhesion of early settlers of dental plaque to the tooth surface has a role in the initiation of the development of dental plaque. The anti-inflammatory action of guava is in its ability to inhibit prostaglandin, kinin, and histamine.

Despite the well-established antimicrobial properties of Guava gel, there is a lack of comprehensive research on their specific effects on periodontal pathogens, including their virulence factors and enzymes. Only a limited number of studies have investigated the efficacy of Guava leaf extract gel as phytomedicines against periodontal pathogens. Moreover, there is a notable absence of literature comparing the effects of Guava extract gel on oral Gram-negative microbes. This research holds significant novelty in its exploration of Guava extract gel for treating Chronic Periodontitis, presenting a pioneering approach in the realm of dental care. The distinctive aspect lies in the incorporation of herbal remedies, specifically Guava extracts, into periodontitis management— an innovative departure from conventional treatments like adjunctive to scaling and root planning in the form of Chlorhexidine which is considered gold standard. Therefore, the present study is planned to evaluate the efficacy of Guava on patients suffering from Chronic periodontitis.

Hence, the current research aims to assess and compare the effectiveness of a gel made from Guava leaf extract gel in treating Chronic Periodontitis with Chlorhexidine gluconate gel.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with mild and moderate Chronic periodontitis.

排除标准

  • Patients with systemic condition and/or have taken an antibiotic for more than 5 days during the last 3 weeks.
  • Patients with severe periodontitis.
  • Pregnant women and lactating mother.
  • Patient who have undergone flap surgery or major periodontal treatment in the past 6 months.

结局指标

主要结局

Plaque Index (PI), Gingival Index (GI), and

时间窗: Baseline, One and Half Months and Three | Months

Papillary Bleeding Index (PBI)

时间窗: Baseline, One and Half Months and Three | Months

次要结局

  • Patients acceptability of the gels in terms of ease(of use, taste & flavor.)

研究者

发起方
Dr Siddhant Bhuyar
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Siddhant Bandopant Bhuyar

Vidarbha Youth Welfare Society Dental College and Hospital

研究点 (1)

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