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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

Sponsor
Tatyasaheb Kore Dental College (Other)
Overall Status
Completed
CT.gov ID
NCT02442453
Collaborator
(none)
100
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

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
  • 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.

  1. To show efficacy of curcuma longa gel as topical antioxidant agent on activity of SOD and lipid peroxidation product MDA.

  2. To compare SOD and MDA levels after SRP and SRP plus topical application of curcuma longa gel.

  3. 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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs [one month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 55 Years
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tatyasaheb Kore Dental College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DR.DHANASHREE RAVINDRA AGARWAL, Dr.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College
    ClinicalTrials.gov Identifier:
    NCT02442453
    Other Study ID Numbers:
    • DHANASHREE786
    First Posted:
    May 13, 2015
    Last Update Posted:
    May 13, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis
    Turmeric extract

    Study Results

    No Results Posted as of May 13, 2015