Chronic Periodontitis Clinical Trial
Official title:
Effect of Ashwagandha (Withania Somnifera) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant and Serum c Reactive Protein Levels in Chronic Generalized Periodontitis- a Randomized Double Blind Clinico-biochemical Trial
Verified date | May 2018 |
Source | Tatyasaheb Kore Dental College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Periodontal disease is an immune-inflammatory disease which consists of connective tissue breakdown, loss of attachment, and alveolar bone loss.In normal physiology, there is an equilibrium maintained between reactive oxygen species (ROS) activity and antioxidant defence capacity. when this equilibrium changes and shifts in favour of ROS, it will result in oxidative stress (OS). Increased levels of acute phase proteins have been associated with gingival inflammation and periodontitis, which reflected the locally stressed environment. it has been well established that in chronic inflammation sites there is over-production of ROS. The human body consists of an array of antioxidant defense mechanisms (non-enzymatic and enzymatic antioxidants) which removes harmful ROS as soon as they are formed and prevent their deleterious effects. Superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase are the enzymatic antioxidants, while the nonenzymatic antioxidants include vitamins E and C, and reduced glutathione. C - reactive protein (CRP) is a plasma protein that reflects a measure of the acute phase response to inflammation and is one of the markers of choice in monitoring this response. Changes in peripheral blood cellular and molecular components can be seen in patients with periodontitis, as periodontitis includes inflammatory changes of the periodontal tissues. Ashwagandha is also known as Indian ginseng and winter cherry. It consists of dried roots of Withania Somnifera (Family: Solanaceae).6 The Sanskrit words ashva meaning horse, and gandha meaning smell together form the name Ashwagandha. Ashwagandha possessed marked anti-inflammatory effect against denaturation of protein in vitro. the effect was plausibly due to the alkaloid and withanolide contents of ashwagandha. It is a multipurpose herb, which acts as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardio protective, thyroid modulating, immunomodulating, antibacterial, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic agent.So, this study is carried out to assess SOD & CRP levels with or without Ashwagandha supplementation as an adjunct to scaling and root planing(SRP) in chronic periodontitis(CP) patients.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 28, 2018 |
Est. primary completion date | February 27, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Patients without any known systemic diseases. - Patients with chronic generalized periodontitis based on CDC 2007 Exclusion Criteria: - Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study. - Subjects who have undergone periodontal treatment within 6 months of inception of study. - Tobacco habits in any form and alcoholics. - Pregnant and lactating women. - Patients on anti-depressant, thyroid, anti- psychiatric, diabetic medications |
Country | Name | City | State |
---|---|---|---|
India | Tatyasaheb Kore Dental College | Kolhapur | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tatyasaheb Kore Dental College |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in c reactive protein | c reactive protein levels by nephelometry | 1 month and 2 months | |
Primary | change in super oxide dismutase | super oxide dismutase levels by biochemical kazaridas method | 1 month and 2 months | |
Primary | change in probing depth | measured with UNC 15 Probe | 1 month and 2 months | |
Primary | change in clinical attachment loss | measured with UNC 15 probe | 1 month and 2 months | |
Secondary | gingival index | clinically assessed its a scale ranging from 0 to 3,in which 0 being the least and 3 being the highest | 1 month and 2 months |
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