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临床试验/NCT05994885
NCT05994885招募中不适用

Prognostic Potentials of E-cadherin and Total Antioxidant Capacity in Gingival Crevicular Fluid of Moderately Deep Periodontal Pockets Treated With Nonsurgical Periodontal Therapy

Ali A Abdulkareem1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Probing pocket depth

研究概览

简要总结

Ability to anticipate the outcomes of periodontal therapy at baseline visit is crucial to outline and customize a treatment plan with predictable outcomes and cost-effectiveness. Presence of diverse range of health/disease-associated molecules in oral environment that reflect health and disease, together with clinical parameters, is an appealing approach to use them as biomarkers to diagnose, predict, and monitor periodontal disease. Among these proteins are E-cad and TAC which available evidence indicate that their concentrations in oral biofluids increase remarkably during periodontitis as compared to healthy periodontium.

详细描述

Loss of attachment and formation of periodontal pockets are hallmarks of periodontitis. The treatment approach is either by nonsurgical or surgical periodontal therapy or a combination of both depending on the severity of the case. In general, sites with moderately deep pockets (4 to 6 mm) are responding favorably to nonsurgical periodontal therapy (NSPT). Nevertheless, some sites exhibit persistent pockets even with multiple treatment sessions which could be attributed to the presence of tissue invaders or aberrant immune response that impede healing process.

Prediction of treatment outcomes based on clinical data is limited and sometimes lacking accuracy. Use of biomarkers that can be non-invasively collected from oral fluids e.g., gingival crevicular fluid (GCF) as diagnostic/predictive tools has gained attention in the last decade. For instance, E-Cadherin (E-cad) and total antioxidant capacity (TAC) are associated with periodontitis. E-cad is a transmembrane glycoprotein that is a key mediator of stable cell-cell adhesion of epithelial cells. E-cadherin-based adherens junctions specialized cell structures that mediate cell-cell adhesion and regulate cytoskeleton reorganization forming a continuous, linear circumferential belt (zonula adherens) around the apical part of the cell. While TAC, defined as the moles of oxidants neutralized by one liter of solution, is a biomarker measuring the antioxidant potential of body fluids.

Available evidence indicates that the concentration of both molecules are substantially increased with increasing severity of periodontitis and vice versa in periodontal health. This suggests the potential of GCF-E-cad and TAC to predict the prognosis following NSPT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

The care provider is not aware about clinical parameters and biochemical analysis of GCF (E-cadherin and total antioxidant capacity).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy adult patients (> 18 years).
  • Periodontitis (interdental clinical attachment loss (CAL) detectable at ≥2 non-adjacent teeth, or buccal/oral CAL of ≥3mm with pocketing of >3mm is detectable at ≥2 teeth). All patients should exhibit generalized periodontitis with pockets of PPD = 4 to 6 mm of any stage, unstable, and grade A to C. Only maxillary teeth with single root will be included.

排除标准

  • Consumption of antibiotics or periodontal treatment 3-months prior to the study.
  • Pregnancy and lactation.
  • History of systemic disease e.g., diabetes mellitus.
  • Patients currently recruited in other trials.
  • Patients not willing to consent.
  • Periodontal pockets ≥ 7mm, active caries, endodontic problem.
  • Multi-rooted teeth will be also considered as exclusion reasons.

结局指标

主要结局

Probing pocket depth

时间窗: Baseline, 1 week, then 1 month and 3 months after treatment

Linear distance, in mm, measured from the gingival margin to the base of periodontal pocket or sulcus.

次要结局

  • Clinical attachment loss(Baseline, 1 week, then 1 month and 3 months after treatment)
  • Bleeding on probing(Baseline, 1 week, then 1 month and 3 months after treatment)
  • Total antioxidant capacity(Baseline, 1 month and 3 months after treatment)
  • Gingival crevicular fluid E-cadherin(Baseline, 1 month and 3 months after treatment)

研究者

发起方
Ali A Abdulkareem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ali A Abdulkareem

Assistant Professor

University of Baghdad

研究点 (1)

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