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
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
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
NCT ID
NCT02442453
First Posted
April 28, 2015
Last Updated
May 8, 2015
Sponsor
Tatyasaheb Kore Dental College
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
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