跳至主要内容
临床试验/CTRI/2024/03/064158
CTRI/2024/03/064158尚未招募不适用

Clinical efficacy of nano-bio-fusion gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis

Dr Shahanaz Shaik1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月23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
30
试验地点
1
主要终点
Probing depth (PD)

研究概览

简要总结

Periodontal disease [PD] is an immuno-inflammatory destructive disease of periodontal tissues characterised by loss of soft tissue attachment and alveolar bone resorption caused by pathogenic microorganisms resulting in pocket formation and or gingival recession.

Owing to the chronic nature of the disease, most of the patients report to the dentist only when the disease has reached the established destructive stage, thus requiring a comprehensive treatment procedure which is time consuming and the outcome may not be promising in most of the cases. It is worth mentioning that the deleterious effects of PD are not limited to the oral cavity, but extends its clutches to gain ready access to the systemic circulation through the pocket epithelium, eliciting host immuno-inflammatory response, eventually resulting in systemic complications. PD starts as an inflammatory reaction confined to the gingival tissue (gingivitis), but when left untreated it progresses to involve the periodontal ligament, cementum and supporting alveolar bone, resulting in pocket formation which provides a favourable environment for the growth of pathogenic anaerobic microorganisms.

The treatment of periodontal pocket by mechanical removal of local factors and disruption of subgingival plaque biofilm is mandatory. Therefore, scaling and root planning treatment of choice of these conditions.

With the growing understanding about microbial etiopathogenesis of PD, the need for development of novel technologies has resulted in the evolution of multiple advanced systemic or local/intra pocket antimicrobial delivery systems. Nevertheless, most of the systemic antimicrobials are associated microbial resistance with its inadvertent use, failure to reach the site of infection and attain adequate concentration and poor tissue penetration. Owing with these disadvantages with systemic antimicrobials local Drug Delivery agents have been introduced. LDDS, the therapeutic goal is achieved by placing the antimicrobial agents directly in the sub gingival sites/periodontal pocket, which releases the active drug in an immediate or controlled/sustained fashion to combat the microbial attack, simultaneously minimizing its undesirable effects on non-oral systemic/body sites. LDDS have several advantages over systemic antimicrobial agents, which include minimally invasive and direct application at the site of infection, avoidance of gastro-intestinal issues and first pass metabolism, reduction in the dose and frequency of drug administration. Placement of LDDS is aided by the presence of periodontal pocket, which acts as natural reservoir in which gingival crevicular fluid (GCF) provides hydrated environment that boosts distribution of the drug throughout the pocket. As an adjacent scaling, many chemical agents such as chlorohexidine, herbal agents such as propolis, aloe vera green tea extracts, neem, curcumin have gained popularity for local drug delivery.Propolis produced by honeybees is a resinous mixture collected from parts of plants, buds, and exudates. In 1908, the first scientific work with propolis, illustrating its composition and pleiotropic property, was published and was first patented in 1968. Nowadays, propolis is a natural remedy in the different formulation in the field of medicine and dentistry. Vitamin C, a key processor of cell growth, healing, and repair of tissue, influences the metabolism of collagen within the periodontium. It also maintains the epithelial barrier function to bacterial products and integrity of periodontal microvasculature. Vitamin E serves as an antioxidant to limit free radical and to protect cells from lipid peroxidation. Vitamin E works in synergistic with Vitamin C and maintains the integrity of the cell membranes.

The oral cavity being a natural moist environment, the potency and effectiveness of the topical application of various agents to prevent progression of disease are markedly reduced. Nano-Bio Fusion (NBF) gingival gel used in the study is a patented scientifically formulated, bio adhesive antioxidant gel harvesting naturally occurring antioxidants for targeted action. It mainly acts based on the NBF technology which allows the ultrafine antioxidants to surpass the moist intraoral environment, enter the cells and rejuvenate, revitalize, support, protect, and optimize gum and soft oral tissue. The natural antioxidant power of propolis, vitamin C, and vitamin E is amplified with Nano Bio-Fusion technology. For example, nano Vitamin C is ten times more potent in hundred times smaller quantities, than Vitamin C on its own. Once applied, NBF gel creates nano-bioactive protective film which results in increased absorption, resulting in improved clinical effectiveness and visible results after application.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1.Age group of 25-55 years 2.Apparently Healthy individual 3.Patient with chronic periodontitis 4.Pocket depth of 4mm to 6mm 5.patient who are willing to given informed consent.

排除标准

  • 1.Histroy of systemic diseases.
  • 2.Smoking 3.Previous history of any periodontal treatment before 6 months.
  • 4.Pregnancy and lactating woman 5.Under medication of any antibiotic/drugs that after the periodontal status.

结局指标

主要结局

Probing depth (PD)

时间窗: baseline and 3 months

Clinical attachment level (CAL)

时间窗: baseline and 3 months

次要结局

  • Plaque index(PI)(Gingival index(GI))

研究者

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

Dr Shahanaz Shaik

KLE VK Institute of Dental Sciences

研究点 (1)

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