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临床试验/NCT03787875
NCT03787875已完成不适用

Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid

University of Valencia0 个研究点目标入组 40 人开始时间: 2016年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Levels of RANKL in crevicular fluid

研究概览

简要总结

Objectives: Alveolar resorption is one of the most important events in periodontitis. Osteoclast activity is regulated by the ratio between receptor activator of NF-κB ligand (RANKL) and osteoprotegerin (OPG). The aim of this study was to evaluate changes in the RANKL/OPG ratio in crevicular fluid after periodontal treatment.

Material and methods: A total of 15 patients with periodontitis were included in the study group. Samples were collected from an area with active periodontitis and a healthy area. The RANKL and OPG levels were measured before and after periodontal scaling and root planing (SRP) treatment. The study group was compared to the control group, which included 10 patients without periodontitis.

详细描述

Material and methods Study design A case-control study was proposed. A group of periodontally healthy subjects was compared to a group of patients with periodontitis before and after scaling and root planing.

Two sites were studied in each subject with periodontitis: one affected site (with periodontitis) and one healthy site (without periodontal disease); the latter site served as a control. Thus, the study units were the healthy and pathological sites before and after SRP treatment.

The masking was triple blind, including the researcher in charge of sample collection, the laboratory technician and the statistician.

Due to the absence of pre-established reference values for the RANKL and OPG concentrations in periodontal health, the results obtained were compared to a control group of subjects with periodontally healthy conditions during the second part of the study.

This protocol was approved by the ethics committee of the University of Valencia (Spain) according to the Declaration of Helsinki. Written informed consent was obtained from the study subjects.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The control group included:
  • 10 periodontally healthy subjects
  • Without signs or symptoms of periodontal disease.
  • The study group included:
  • 15 subjects diagnosed with mild or advanced chronic periodontitis.
  • One non-affected single-rooted tooth (healthy site)
  • Single-rooted tooth with periodontitis (periodontitis site) with the following features: with clinical attachment loss equal to or greater than 6 mm and bleeding upon probing.

排除标准

  • Subjects with aggressive periodontitis
  • Systemic diseases or consumption of drugs affecting bone metabolism
  • Antibiotic, anti-inflammatory or contraceptive treatment for the last three months prior to study initiation
  • Antiplatelet therapy for the last 7 days prior to study onset
  • Primary or secondary occlusal trauma
  • Periapical or periodontal abscess in some of the teeth included in the study
  • Periodontal treatment within the last 6 months
  • Orthodontic treatment
  • Pregnant or breastfeeding.

结局指标

主要结局

Levels of RANKL in crevicular fluid

时间窗: 49 days

receptor activator of NF-κB ligand.RANKL is a protein that determines the activation of osteoclasts by binding to the RANK membrane receptor that preosteoclates possess. The ranks wi be measured in μg / μl.

Levels of OPG in crevicular fluid

时间窗: 49 days

osteoprotegerin.Osteoprogesterian is a soluble protein that acts as a decoy blocked RANK receptor and thus initiating osteoclastogenesis. The opg will be measured in μg / μl.

次要结局

  • probing depth(49 days)
  • clinical attachment level(49 days)
  • bleeding upon probing(49 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andres Lopez Roldan

Associate professor

University of Valencia

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