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临床试验/CTRI/2019/04/018697
CTRI/2019/04/018697已完成4 期

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 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年4月23日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Probing pocket depth reduction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Probing pocket depth reduction

时间窗: baseline, post-operatively 3 months and 6 months

次要结局

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

研究者

发起方
not applicable
申办方类型
Other [not applicable]

研究点 (1)

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