Assessment of the efficacy of curcumin loaded silver nano particle film on wound healing after periodontal surgery – A randomized controlled trial
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
- Wound healing Score - Wound healing will be assessed using Landry, Turnbull and Howley Healing Index (1988)
研究概览
简要总结
Ø Periodontitis is one of the most common ailments affecting the teeth, leading to the destruction of the supporting and surrounding tooth structure. Periodontal disease is the most common oral disease with a prevalence of 20–50% of the world population, and has a multifactorial origin, with the primary causative agent being the bacterial colonization in the oral tissue.The periodontal wound healing process is slightly different from cutaneous wound healing and is similar to fetal healing, being almost scar-free. The periodontal dressings are protective material placed over the wound created by periodontal surgical procedures. They are commonly placed following various periodontal surgical procedures including gingivectomies, flap procedures, crown lengthening, mucogingival procedure, and most commonly after periodontal regeneration.
Ø The periodontal dressings (pack) are protective materials applied over the wound created by periodontal surgical procedures. Periodontal dressing protects the surgical wound from saliva, food stagnation and trauma, thus making post-operative period comfortable and healing more favourable. Thus, the periodontal dressing protects the wound indirectly from infection. The main objectives of periodontal dressings are to obtain an optimized healing and ensure minimum discomfort to the patient. Wound protection and patient’s comfort are the main purpose of periodontal dressing.
Ø However, a number of clinical trials have reported plaque accumulation beneath these dressings, leading to inflammation in the tissues and transient bacteremia. The value of periodontal dressing and their effects on periodontal wound healing has been questioned for many years.
Ø This encouraged the invention of drug-loaded dressings, which act as a barrier to microorganisms when applied on a wound, thus stimulating the wound-healing environment by preventing secondary infections. Various agents have been tested such as chlorhexidine digluconate salts, zinc bacitracin, and tetracycline. Among the different antimicrobial agents, silver has been used widely due to many benefits, including multi-level antibacterial effect on cells with low systemic toxicity.
Ø The silver nanoparticles (NPs) are being increasingly used nowadays as wound dressings, contraceptive devices, surgical instruments, and bone prostheses. There is increasing literature to support that silver NPs can promote wound healing through anti-inflammatory properties. Furthermore, the levels of pro-inflammatory markers have been found to be significantly reduced in animals treated with silver nanoparticles. These results suggest that silver nanoparticles can be involved in altering or suppressing inflammatory events in the early phases of wound healing, and the use of silver nanoparticles may be clinically applicable to many conditions. A systematic review by Song and Gealso (2019) compiled in sufficient details about their applications in prevention of oral diseases including periodontal infections and peri-implant infections inhibiting both Gram-positive and Gram-negative species.
Ø It has been identified that along with the currently available drugs for wound healing, herbal extracts have also been found to have wound healing potential. Curcumin is well known for its anti-inflammatory, antimicrobial, antioxidant and wound-healing properties. Curcumin also has a good safety profile and is termed as a generally regarded as safe ingredient by the US Food and Drug Administration. In addition to this, it is also highly economical, is easily available, and has a multitargeted mode of action on the various molecular signalling pathways, unlike NSAIDs. In spite of the promising biological effects, the clinical application of curcumin is still a challenge due to its poor bioavailability due to poor absorption, rapid metabolism, and rapid systemic elimination.
Ø To overcome these limitations, curcumin has also been studied in the form of local drug delivery agents such as gels, mouth rinses, subgingival irrigants, and curcumin incorporated collagen fibres, which have shown to achieve a higher concentration in the oral cavity as compared to the oral administration.
Ø Mucoadhesive films are a form of local drug delivery system which employs the transmucosal route of drug delivery. The films provide release of drug at the desired site which gives better drug absorption. There is limited literature available on wound healing potential of curcumin in the form of a mucoadhesive film after periodontal surgeries.
Ø Hence, keeping all these data in mind, the aim of this study is to assess the efficacy of curcumin loaded silver nano particle film on wound healing after periodontal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •INCLUSION CRITERIA: 1.Systemically healthy patients requiring periodontal therapy.
- •periodontal flap surgery. 2.Patients between the age of 35 – 60 years. 3.Patients willing to participate in the study.
排除标准
- •EXCLUSION CRITERIA: 1.Pregnant Women and Lactating Mothers.
- •2.Patients who are medically compromised and are under therapeutic regimen that may alter the probability of tissue healing.
- •3.Patients who underwent periodontal therapy in the past 6 months.
- •4.Patients who were on antibiotic therapy or NSAIDs therapy in the past 6 months.
- •5.Smokers or patients with any habit history.
- •6.Patients who are known or suspected to be allergic to curcumin and silver.
结局指标
主要结局
Wound healing Score - Wound healing will be assessed using Landry, Turnbull and Howley Healing Index (1988)
时间窗: 7th day and 14th day
次要结局
- Colony Forming Units (CFU/ml)(Base line and 7th day)
研究者
Dr Nivethitha D
KLE VK Institute of Dental Sciences
