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CompletedNCT02442453Updated May 13, 2015

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

A Phase 4 interventional study of Topical application of curenext gel and Placebo in Chronic Periodontitis, sponsored by Tatyasaheb Kore Dental College. Completed. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-13.

Sponsored by Tatyasaheb Kore Dental College · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.
  1. To compare SOD and MDA levels after SRP and SRP plus topical application of curcuma longa gel.
  1. 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).
02

Conditions studied

  • Chronic Periodontitis
03

In context

Periodontitis

1,637 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 100 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Tatyasaheb Kore Dental College is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugTopical application of curenext gel

    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

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Superoxide dismutase antioxidant enzyme levels in saliva of chronic periodontitis subjetcs

    Time frame: one month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02442453
Lead sponsor
Tatyasaheb Kore Dental College
Responsible party
DR.DHANASHREE RAVINDRA AGARWAL (Dr.DHANASHREE RAVINDRA AGARWAL, Tatyasaheb Kore Dental College) — Principal investigator
First posted
May 13, 2015
Start date
Jan 2014
Primary completion
Nov 2014
Completion
Dec 2014
Last update
May 13, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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