Comparison of Salivary Interleukin-1β and Matrix Metalloproteinase-8 Levels in Individuals With Chronic Periodontitis Before and After Treatment With Nigella Sativa (Kalonji) Oil
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Levels of IL 1-Beta and MMP-8
研究概览
简要总结
Periodontitis is an infectious inflammatory disease affecting the periodontal tissue (Gingivae, alveolar bone, periodontal ligament and cementum). Chronic Periodontitis is considered to be the most prevalent disease after dental caries which is linked to increased levels of C- reactive protein, interleukins and matrix metallo-proteinases. Interleukin- 1β and Matrix metalloproteinase-8 have been shown to be robust markers of inflammatory cascade of chronic periodontitis.Various treatment modalities including scaling and root planing, toothpastes and chlorhexidine based mouthwashes have been are known to be associated with various side effects like teeth staining, altered taste sensation, mucosal burning. Hence,the use of natural medicaments could provide a better alternative because of their fewer side effects and cost effectiveness.
详细描述
Periodontal disease is one of the most common diseases in humans and is responsible for most of the tooth loss in adults. World health Organisation report of 2005 described that the global problem persisted with the worldwide oral diseases such as dental caries, periodontal disease, tooth loss, oral mucosal lesions and oro-pharyngeal cancer. According to a local study the prevalence of periodontitis is found to be more in males of older age group and more in rural areas owing to the lack of awareness of importance of oral hygiene.
Apart from various conventional treatment option for periodontitis a number of herbal medicinal intervention have been used for its treatment. Plant extracts and herbs that have been used previously used for periodontal therapy include Salvadora persica, Arnica Montana and Hamamelis virginiana which have been shown to exhibit antibacterial activity against periodonto-pathic bacteria. Phytomedicines (Medicines derived from herbal plants) like indian gum arabic, aloe vera, nim, carvacrol, garlic, wild coffee and propolis resin have been used in dentistry as anti-inflammatory, antibiotics, analgesic and hypnotic agents. Propolis resin, guava and triphala have been also been used for the treatment of periodontitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple Blind
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy individual
- •Individuals diagnosed with chronic periodontitis according to the WHO criteria.
- •Age 19 to 40 years.
排除标准
- •Patients with gingivitis only.
- •Patients using tobacco products and alcohol.
- •Underlying systemic pathology such as diabetes mellitus, cardiovascular disease, arthritis etc.
- •Oral mucosal pre-neoplastic lesions (leukoplakia, erthroplakia, lichen planus) and oral carcinomas.
- •Obese patients.
- •Pregnant females.
- •Xerostomia.
- •Previous history of radiotherapy or chemotherapy.
- •Positive history of oral prophylactic procedures (mouthwashes and antibiotics).
- •Positive history of any periodontal treatment during last 6 months.
- •Positive antibiotic therapy history within last month of study.
研究组 & 干预措施
Normal Saline
The group contains healthy individuals with chronic periodontitis who will receive Normal Saline as placebo
干预措施: Normal saline (Drug)
Nigella Sativa
The group contains healthy individuals with chronic periodontitis who will receive Nigella sativa Oil as intervention
干预措施: Nigella Sativa Oil (Drug)
结局指标
主要结局
Levels of IL 1-Beta and MMP-8
时间窗: 2 weeks
These inflammatory marker will be measured in patients saliva again after 2 weeks. There will be reduction in their levels.
次要结局
未报告次要终点
研究者
Dr. Ghazala Hassan
Research Scholar
University of Health Sciences Lahore