Clinical efficacy of combined Curcumin and Resveratrol oral in-situ gels as local therapeutics in the treatment of stage I and stage II Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
Periodontal inflammation is initiated by gram-negative tooth-associated microbial flora which elicits a host response, resulting in progressive, irreversible bone and soft tissue destruction. The putative oral pathogens such as Agreegatibacter Actinomycetemcomitans, and Porphyromonas species produce endodontopathogenic materials activating monocytes/macrophages to produce pro-inflammatory vasoactive mediators such as prostaglandins PGE2 and IL-1 which suppress host defense mechanism and destroy periodontal tissues.Research in Phyto sciences, an emerging multidisciplinary science has revealed various medicinal plants holding antimicrobial activity with fewer side effects and decreased toxicity. Extracts of these medicinal plants snatched the eyes of various investigators to evaluate their efficacy.Curcumin has anti-inflammatory, anti microbial, anti-oxidant, antiseptic and anti-mutagenic effects. These properties help in reducing the function of neutrophils during inflammation and inhibit free radical formation.Resveratrol is another herbal medicine with anti inflammatory, anti-microbial and anti- carcinogenic properties. in crude form, both curcumin and trans-resveratrol demonstrate low water solubility, poor bioavailability, rapid metabolism, and clearance.Further to this, trans-resveratrol is also photosensitive and stable within a narrow optimal pH range (pH 6–8), making stability an issue.One natural way to improve the pharmacological profile of curcumin and trans-resveratrol is via combinations that encourage synergy. For example, trans-resveratrol and curcumin have been found to have a synergistic effect when combined with each other.Taking the above facts into account, the present study is planned to compare the clinical efficacy of Curcumin, Resveratrol and Chlorhexidine oral in-situ gels as an adjunct to scaling and root planning in the management of stage-1 and stage-2 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
- •Patients with Stage I and Stage II Periodontitis.
- •Patients within the age group of 35 to 44 years of age for both genders.
- •Subjects with no history of allergies to the components used in the study
- •Patients with standard oral hygiene practices
- •Apparently healthy individuals.
排除标准
- •Patients with habits like any form of tobacco, or alcohol consumption.
- •Systemically compromised patients
- •Pregnant women or lactating mothers
- •Patients who are on medication that influences periodontal health.
- •Patients with impacted teeth, non-functional teeth or prosthetic restorations
- •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,3 months
2.Reduction of Periodontal Pocket Probing Depth
时间窗: baseline,1 month,3 months
次要结局
- reduced inflammation(baseline,1 month,3 months)
研究者
Dr Boyapati Ramanarayana
SIBAR INSTITUTE OF DENTAL SCIENCES