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
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
Dr Boyapati Ramanarayana
SIBAR INSTITUTE OF DENTAL SCIENCES
