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

NCT02442453 | Completed Phase 4

• 1 other identifier: DHANASHREE786
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs

  one month

Study Arms (2)

curcuma longa

ACTIVE COMPARATOR

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

Placebo gel

PLACEBO COMPARATOR

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

Interventions

Topical application of curenext gel DRUG

Topical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects

Also known as: curcuma longa topical gel, curenext gel

curcuma longa

Placebo DRUG

Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects

Placebo gel

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.DHANASHREE RAVINDRA AGARWAL

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 13, 2015
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-04