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Clinical Trials/CTRI/2019/04/018697
CTRI/2019/04/018697CompletedPhase 4

Comparison of Effectiveness of Subgingivally Delivered Boric acid gel and Curcumin gel as an adjunct to Mechanotherapy in Chronic Periodontitis: A clinical study

not applicable1 site in 1 country26 target enrollmentStarted: April 23, 2019Last updated:

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
26
Locations
1
Primary Endpoint
Probing pocket depth reduction

Study Overview

Brief Summary

Periodontitis,a chronic inflammatory disease, is induced by bacterial biofilms that initiatehost response in gingival connective tissue. It is considered an infection because there is abacterial etiology and an immune response. Sub gingivalenvironment is Ideal for pathogenic bacteria andSub gingival microorganisms are the principleetiologic factor in the development of periodontitis. Conventionaltherapy (e.g., scaling and root planing [SRP] and ultrasonic debridement)without adjunctive chemotherapy is often sufficient to suppress bacterialpathogens, thereby attaining periodontal health. Local delivery of antimicrobial agents in Periodonticsimplies antimicrobial therapy placed directly in the sub gingival region. Borinic acid are quinoline esters, arecently-identified class of new antibacterial compounds that contains boron. Itplays a role in inflammatory and immune response regulation. Italso plays a vital role in osteogenesis and the maintenance of bones.  Curcumin, the primary active constituent of turmeric exhibits anti-inflammatory, anti-oxidant, anticarcinogenic, antiviral, and antimicrobial activities. Therefore, the present study will be undertaken to evaluate and compare the effectiveness of boric acid gel and curcumin gel  as an adjunct to scaling and root planing in patients with chronic periodontitis.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients motivated to have the therapy and willing to complete the follow-up.
  • Patients with a minimum of 20 teeth.
  • Subjects who readily give informed consent for the study.
  • Systemically healthy subjects, with deep pockets.
  • Patients with no history of periodontal therapy ij the preceding 6 months or under any antibiotic therapy.

Exclusion Criteria

  • Patients on systemic boron therapy, those with a known or suspected allergy to boron supplementation or curcumin.
  • Patients who have undergone periodontal therapy in the last 6 months.
  • Patients who were taking and had consumed vitamin supplements, anti-inflammatory agents, or statins in the previous 3 months.
  • Patients with any systemic disorder affecting periodontal health.
  • Patients with infectious conditions other than periodontitis.
  • Regular users of mouthwashes.
  • Chronic alcoholics
  • Those with aggressive periodontitis.
  • Immunocompromised and systemically unhealthy patients.
  • Pregnant or lactating females.

Outcomes

Primary Outcomes

Probing pocket depth reduction

Time Frame: baseline, post-operatively 3 months and 6 months

Secondary Outcomes

  • Clinical attachment level gain(baseline, post-operatively 3 months and 6 months)

Investigators

Sponsor
not applicable
Sponsor Class
Other [not applicable]

Study Sites (1)

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