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临床试验/CTRI/2024/09/073289
CTRI/2024/09/073289尚未招募2 期

Evaluation of clinical efficacy of Punica granatum epicarp extract, seed and whole fruit juice concentrate loaded thermo-reversible hydrogel as local drug delivery system in the treatment of Stage I and Stage II Periodontitis

Dr Boyapati Ramanarayana1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1. Improvement in clinical attachment level

研究概览

简要总结

The primary goal of periodontal therapy is removal of the biofilm deposits and create an environment conducive for the shift of microbiome from pathobionts to symbionts. This is often achieved by the gold standard- scaling and root planning (SRP) procedure, alone or with adjunctive administration of systemic or local antimicrobial agents, and surgical periodontal therapy, if required. However, use of systemic antimicrobials were shown to have adverse effects such as drug toxicity, acquired bacterial resistance, poor patient compliance and unwanted drug interactions. To tackle these limitations, local delivery of antibacterial agents into periodontal pocket is being extensively used. The benefits of using local drug delivery include better patient compliance, enhanced pharmacokinetic response, greater access and ability to position the drug adjacent to the disease and ability to lower total dosage of the drug at a more controlled concentration.

Similarly, phytotherapy has long been a source of medicinal products and over the years there have been many attempts to use herbal medicines for the treatment of chronic periodontitis, with the advantage of few side effects and cost-effectiveness.Natural products are the drugs of choice due to novelty in their chemical structure and mechanism of action. Ayurvedic medicine frequently refers to Punica granatum, sometimes known as pomegranate, as "a pharmacy unto itself" because of its prophylactic, anthelmintic, styptic, laxative, diuretic, bactericidal, and antifungal qualities. Peel (the inedible portion) makes up about half of the weight of the fruit; the remaining 50% is made up of seeds (10%), juice (40%) and arils (the edible portion). Bioactive substances include punicalagins, flavones, flavanones, anthocyanins, ascorbic acid, ellagic acid, gallic acid, caffeic acid, catechin, epigallocatechin, quercetin, tannins, and rutin are abundant in the peel and juice.

The remarkable antioxidant, anti-inflammatory, anti-atherosclerotic, antihypertensive, anti-mutagenic and wound-healing qualities of P. granatum fruit are attributed to these substances.Due to its unique properties it is used extensively in the treatment of periodontitis.Taking the above facts into account, the present study is planned prepare and evaluate the clinical efficacy of pomegranate fruit extract loaded thermo-reversible hydrogel as an adjunct to scaling and root planning in the management of Stage I and stage II Periodontitis.

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, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
35.00 Year(s) 至 44.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients with Stage I and Stage II Periodontitis.
  • 2.Patients within the age group of 35 to 44 years of age for both genders.
  • 3.Subjects with no history of allergies to the components used in the study 4.Apparently healthy individuals.

排除标准

  • 1.Patients with habits like any form of tobacco or alcohol consumption.
  • 2.Systemically compromised patients 3.Pregnant women or lactating mothers 4.Patients who are on medication that influences periodontal health.
  • 5.Patients with impacted teeth, non-functional teeth or prosthetic restorations 6.Patients who will not be able to be attend for follow up visits.

结局指标

主要结局

1. Improvement in clinical attachment level

时间窗: baseline, 1 month and 3 months

2.Reduction of Periodontal Pocket Probing

时间窗: baseline, 1 month and 3 months

Depth

时间窗: baseline, 1 month and 3 months

次要结局

  • better wound healing (PISA index)(baseline,1 month and 3 months)

研究者

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

Dr Boyapati Ramanarayana

SIBAR INSTITUTE OF DENTAL SCIENCES

研究点 (1)

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