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临床试验/NCT02835898
NCT02835898已完成不适用

The Effect of Periodontal Therapy on Epigenetic Changes: A Pilot Study

University of Milan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy

研究概览

简要总结

Objective: The aim of this pilot study is to evaluate the alterations of epigenetic patterns in periodontally diseased individuals, before and after periodontal treatment, also in comparison to periodontally healthy patients.

Materials & methods: Twenty patients were voluntarily enrolled in two groups: 10 participants with healthy periodontium, and 10 participants with chronic periodontitis. Clinical parameters were recorded and gingival biopsies were collected within the following timelines: At baseline (for both groups), after 15 days (for the diseased group only) and after two months (for the diseased group only).

详细描述

Study Design Baseline: Before harvesting gingival biopsies, bleeding on probing (BOP), periodontal pocket depth (PPD) and clinical attachment level (CAL) were registered at the biopsy site, for all study participants. Following the registration of the clinical parameters, gingival biopsies were obtained from the periodontally-healthy individuals during crown lengthening surgery or surgical removal of wisdom teeth. In the periodontally-diseased group, biopsies were harvested from two sites: healthy site and periodontally-involved site. After harvesting of biopsies, patients with periodontal disease underwent scaling and root planing.

Two weeks after periodontal treatment: Clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns (DNA methylation) were altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups.

Two months after initial periodontal treatment: Clinical parameters were registered and gingival biopsies were harvested (from two sites) for the periodontally-diseased group only, to evaluate if the epigenetic patterns were still altered by conventional periodontal therapy, in comparison to the patterns observed at baseline for both diseased and healthy groups, and at 15 days for the diseased group.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
26 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants should be systemically healthy
  • All patients should be non-smokers
  • Study participants should not be on antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within one month before enrolment in the study
  • All participants should be of a Caucasian ethnicity

排除标准

  • Patients with systemic diseases
  • Smoking patients
  • Patients taking antibiotics or NSAIDs

结局指标

主要结局

Changes in in the levels of DNA methylation (type of epigenetic modification) following periodontal therapy

时间窗: 0, 15 days after periodontal therapy, 2 months after periodontal therapy

次要结局

未报告次要终点

研究者

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

Giulio Rasperini

Professor of periodontology

University of Milan

研究点 (1)

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