Effect of Scaling and Root Planing Along With Topical Application of Commercially Available Curcuma Longa Gel on Superoxide Dismutase and Malondialdehyde Levels in Saliva of Chronic Periodontitis Patients
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|ClinicalTrials.gov Identifier: NCT02442453|
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Periodontitis is initiated by microbial biofilm but its progression is mediated by an abnormal host response to biofilm microorganisms.
In a myriad of possible mechanisms that cause periodontal tissue destruction reactive oxygen species (ROS) play an important role. Imbalance between antioxidant defense system of body and ROS lead to a deleterious situation called oxidative stress.
Superoxide dismutase (SOD) is the key enzyme of body's antioxidant defense system whereas malondialdehyde (MDA) is product of lipid peroxidation due to ROS. Free radicals and ROS have short half lives in vivo of 10-6 to 10-9 seconds. Hence measurement of ROS is done by measuring the concentration of biomarkers of tissue destruction.
For treating periodontal disease, conventional mechanical therapy comprising of scaling and root planing (SRP) along with timely maintenance has been a gold standard and any other therapy considered for treating periodontitis should always be used as an adjunctive and never in lieu of it.
Curcumin, a hydrophobic polyphenol, is a principal active constituent of turmeric. Mechanism of action of curcumin is twofold-its role as a strong antioxidant and as a strong antibacterial. Its analgesic, anti-inflammatory and antiseptic properties offer additional benefits.Periodontitis is a chronic disease of oral cavity accompanied by increased oxidative stress. Therefore the clinical application of a natural antioxidant in the form of curcuma longa can be beneficial in reducing oxidative stress and as an adjuvant in treatment of chronic periodontitis.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: Topical application of curenext gel Drug: Placebo||Phase 4|
Aim was to establish efficacy of curcuma longa gel as a topical antioxidant to alleviate oxidative stress associated with chronic periodontitis.The objectives were-1) To evaluate the presence of oxidative stress by biochemical evaluation of SOD levels and free radical damage in the form of MDA levels in whole saliva of chronic periodontitis patients.
2) To show efficacy of curcuma longa gel as topical antioxidant agent on activity of SOD and lipid peroxidation product MDA.
3) To compare SOD and MDA levels after SRP and SRP plus topical application of curcuma longa gel.
4) To compare the clinical parameters such as Plaque index (PI), Gingival index (GI), Sulcus bleeding index (SBI), Probing depth (PD), Clinical attachment level (CAL) between test group (TG) and control group (CG).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: curcuma longa
curenext gel containing curcuma longa i.e. turmeric has strong antioxidant and antiinflammatory properties.
Test group:Topical application twice daily for ten minutes after brushing for four weeks.
Drug: Topical application of curenext gel
Topical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects
Placebo Comparator: Placebo gel
Placebo gel consists of corbopol 934 polymer and triethonalamine. Control group:Topical application twice daily for ten minutes after brushing for four weeks.
Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects
- Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs [ Time Frame: one month ]