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临床试验/NCT04177732
NCT04177732Unknown不适用

Assessment of Efficacy of Calprotectin and Cross-linked N-telopeptides of Type I Collagen Levels in Crevicular Fluid as a Biomarker in Patients With Peri-implantitis: A Clinical Study

Mansour Assery0 个研究点目标入组 10 人开始时间: 2019年12月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
10
主要终点
Cross-linked N-telopeptides concentration in GCF

研究概览

简要总结

The study aims to assess the efficacy of Calprotectin and cross-linked N-telopeptides of type I collagen levels in crevicular fluid as a biomarker in patients with peri-implantitis.

详细描述

Ethical approval will be obtained from the ethical committee of the Riyadh Elm University and written consent will be obtained from all the patients after explaining in detail the entire research protocol.

Inclusion criteria for the present study:

  • 10 patients who underwent dental implant procedure five to ten years ago; among these- 5 patients will be with healthy peri-implant status and 5 patients with presence of peri-implant diseases
  • Patients of comparable age and gender distribution- Patients within the age group of 25 to 45 years; and 3 males and 2 females in peri-implant diseases group and 3 males and 2 females in healthy peri-implant status group
  • Patients with negative history of any systemic illness, metabolic disease.
  • Patients with negative history of antibiotic therapy in past ninety days.

After collecting the PICF and GCF, examination of probing depth (PD), bleeding on probing (BOP) and gingival index (GI) will be done.Modified Löe and Silness criteria will be used for evaluating the GI score.Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment. Periodontal sites with PD of equal to or more than 3mm with GI score of equal to or more than 1mm and presence or absence of BOP, will be categorized as peri-implant disease sites. Periodontal sites with PD of less than 3mm with GI score of 0 and absence of BOP will be categorized as healthy implant sites. Sterile paper strips will be used for collecting PICF samples, followed by PICF sample preparation using modified criteria described previously in the literature. Isolation of the PICF sampling sites will be done using cotton roles. This will be followed by removal of supra-gingival plaques and gentle air drying. Insertion of the periopaper will be done into the peri-implant crevice and will be kept there for thirty seconds. Periotron will be used for measuring the volume of PICF. Further, all the samples will be sent to laboratory where ELISA technique will be used for measuring the calprotectin

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

盲法说明

No masking

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • •Patients with history of any systemic illness, metabolic disease.
  • •Patients with history of antibiotic therapy in past ninety days.

研究组 & 干预措施

Healthy peri-implant status

Other

Patient with healthy peri-implant status

干预措施: Collection of sulcular (crevicular) fluid (Diagnostic Test)

Healthy peri-implant status

Other

Patient with healthy peri-implant status

干预措施: Probing depth (Diagnostic Test)

Healthy peri-implant status

Other

Patient with healthy peri-implant status

干预措施: Bleeding on probing (Diagnostic Test)

Healthy peri-implant status

Other

Patient with healthy peri-implant status

干预措施: Gingival index (Diagnostic Test)

Healthy peri-implant status

Other

Patient with healthy peri-implant status

干预措施: Bone loss rate of alveolar bone (Diagnostic Test)

Presence of peri-implant diseases

Other

Patients with presence of peri-implant diseases

干预措施: Collection of sulcular (crevicular) fluid (Diagnostic Test)

Presence of peri-implant diseases

Other

Patients with presence of peri-implant diseases

干预措施: Probing depth (Diagnostic Test)

Presence of peri-implant diseases

Other

Patients with presence of peri-implant diseases

干预措施: Bleeding on probing (Diagnostic Test)

Presence of peri-implant diseases

Other

Patients with presence of peri-implant diseases

干预措施: Gingival index (Diagnostic Test)

Presence of peri-implant diseases

Other

Patients with presence of peri-implant diseases

干预措施: Bone loss rate of alveolar bone (Diagnostic Test)

结局指标

主要结局

Cross-linked N-telopeptides concentration in GCF

时间窗: 3 weeks

One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation

Calprotectin concentration in GCF

时间窗: 3 weeks

One of inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with bone inflammation

次要结局

未报告次要终点

研究者

发起方
Mansour Assery
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mansour Assery

Consultant in Prosthodontics & Dental Implant

Riyadh Elm University

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