search
Back to results

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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topical application of curenext gel
Placebo
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    curcuma longa

    Placebo gel

    Arm Description

    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.

    Placebo gel consists of corbopol 934 polymer and triethonalamine. Control group:Topical application twice daily for ten minutes after brushing for four weeks.

    Outcomes

    Primary Outcome Measures

    Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2015
    Last Updated
    May 8, 2015
    Sponsor
    Tatyasaheb Kore Dental College
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02442453
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tatyasaheb Kore Dental College

    4. Oversight

    5. 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    curcuma longa
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo gel
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo gel consists of corbopol 934 polymer and triethonalamine. Control group:Topical application twice daily for ten minutes after brushing for four weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical application of curenext gel
    Other Intervention Name(s)
    curcuma longa topical gel, curenext gel
    Intervention Description
    Topical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects
    Primary Outcome Measure Information:
    Title
    Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs
    Time Frame
    one month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients within age group of 30 to 55 years. Systemically healthy individuals. Patients with chronic generalized periodontitis (based on American Academy of Periodontology classification 1999). Exclusion Criteria: 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). Patients on antioxidants, antibiotics and anti-inflammatory drugs. Those receiving periodontal treatment in last six months prior to inception of study History of smoking, tobacco chewing, alcohol consumption. Pregnant and lactating women.

    12. IPD Sharing Statement

    Learn more about this trial

    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

    We'll reach out to this number within 24 hrs