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

NCT ID: NCT02442453

Last Updated: 2015-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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).

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Topical application of curenext gel

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Topical application of curenext gel

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

curcuma longa topical gel; curenext gel

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tatyasaheb Kore Dental College

OTHER

Sponsor Role: lead

Responsible Party

DR.DHANASHREE RAVINDRA AGARWAL

Dr.DHANASHREE RAVINDRA AGARWAL

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

DHANASHREE786

Identifier Type: -

Identifier Source: org_study_id