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临床试验/CTRI/2020/11/029299
CTRI/2020/11/029299尚未招募2 期

EFFECT OF SCALING, ROOT PLANING AND SCALING, ROOT PLANING WITH LASER DEBRIDEMENT ON THE LEVELS OF INTERLEUKIN - 12 IN PATIENTS WITH CHRONIC PERIODONTITIS

Rajarajeswari Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年11月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Gingival index

研究概览

简要总结

Periodontal disease results from release ofinflammatory mediators and the consequence is a significant breakdown of toothsupporting tissues, finally leading to tooth loss.  The interplay between periodontal pathogensand the inflammatory immune system leads to the development of chronicinflammation. The intensity, duration and resolution of inflammation depend onshifting balance between the activities of pro inflammatory cytokines and antiinflammatory cytokines during the periodontal inflammation. Cytokines areconsidered to play an important role in the initiation, progression and thehost modulation of periodontal disease. Interleukin (IL)-12 regulates thebalance between Th1 and Th2 cells by inducing naive T cells in a Th1-speciï¬cmanner and stimulating T cells and natural killer cells to synthesize multiplepro inflammatory cytokines [Interferon (IFN)-γ, IL-1β, Tumour Necrosis Factor(TNF)-α, IL-8]. Failure to resolve inflammatory periodontal disease may be theresult of an imbalance in both Th1/Th2 response and pro inflammatory and anti inflammatorycytokines. In humans, the major effect of IL-12 is to stimulate IFN-γ   production by Th1 cells and regulate thetransition from an early innate immune response to an adaptive immune response.These T-helper type 1 (Th1), Th2 and monocyte which are derived from cytokinesin gingival tissues, the  Gingival CrevicularFluid (GCF) is  involved in periodontalinflammation. IL - 12   is  produced by  monocytes, macrophages and neutrophils.IL - 12 is comprised of two disulphide – linkedprotein subunits designated p35 and p40, which are encoded by two differentgenes. Both subunits have to be produced within the same cell to obtain thebiologically active dimmer designated p70 .  The importance of IL-12 is not limited toinitiating an immune response, but may contribute to maintaining immunitybecause Th1 responses rapidly fade in the absence of IL-12. The presence orabsence of IL-12 will then determine whether a Th1 or Th2 response predominateswith periodontal disease progression. IL-12  has multiple biological activities.  IL-12 might be potentially useful indistinguishing health from disease and monitoring periodontal disease activity. Lasers have been suggested as a new alternativefor the treatment of periodontal therapy. They are used due to theirantibacterial potential by direct ablation, thermal denaturation anddestruction of bacterial cells. Diode lasers help to reduce subgingivalmicrobiota thus providing sites for new connective tissue attachment. It alsohelps in the promotion of hemostasis, has detoxifying effects and enhanceshealing. the need of thisstudy is to assess the levels of  IL-12before and after Non- surgical periodontaltherapy and Sulcular Debridement with diode laser and to assess and comparethese levels.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Open Label

入排标准

年龄范围
25.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • •Male and female subjects aged between 25 to 45 years.
  • Subjects with good general health.
  • Should have mild to moderate periodontitis with probing depth less than 4mm Should have severe chronic periodontitis with probing depth more than 5mm.

排除标准

  • Patients with systemic illness known to affect the outcomes of periodontal therapy Patients on any medication taken within the last 6 months which may alter the periodontal status Individuals allergic to medications Pregnant or lactating women.

结局指标

主要结局

Gingival index

时间窗: baseline one month three months

Plaque index

时间窗: baseline one month three months

Pocket probing depth

时间窗: baseline one month three months

次要结局

  • Changes in Gingival index scores(Plaque index score and)

研究者

发起方
Rajarajeswari Dental College and Hospital
申办方类型
Other [Private Dental College and Hospital]

研究点 (1)

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