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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02442453
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):
DR.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College

Brief Summary:

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

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
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
Other Names:
  • curcuma longa topical gel
  • curenext gel

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.
Drug: Placebo
Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects

Primary Outcome Measures :
  1. Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs [ Time Frame: one month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients within age group of 30 to 55 years.
  2. Systemically healthy individuals.
  3. Patients with chronic generalized periodontitis (based on American Academy of Periodontology classification 1999).

Exclusion Criteria:

  1. Patients with systemic illnesses (i.e., diabetes mellitus, cancer, human immunodeficiency syndrome, bone metabolic diseases, or disorders that compromise wound healing, radiation, or immunosuppressive therapy, xerostomia).
  2. Patients on antioxidants, antibiotics and anti-inflammatory drugs.
  3. Those receiving periodontal treatment in last six months prior to inception of study
  4. History of smoking, tobacco chewing, alcohol consumption.
  5. Pregnant and lactating women.
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Responsible Party: DR.DHANASHREE RAVINDRA AGARWAL, Dr.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College Identifier: NCT02442453    
Other Study ID Numbers: DHANASHREE786
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Turmeric extract
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs