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Periodontal Disease in Patients With Lynch Syndrome (SMILy_25)

2026年5月18日 更新者:Rotundo Roberto

Periodontal Disease in Patients With Lynch Syndrome: a Retrospective Observational, Monocentric Case-control Study

The field of human microbiome research has undergone a revolution in its approach toward understanding how microorganisms influence the physiology of their host 1. The influence of the oral microbiota is not confined to this location 2. Periodontitis is a "chronic inflammatory disease associated with dysbiotic plaque biofilms and characterized by a progressive destruction of the tooth supporting apparatus"3. Given these observations, the central research question of the present study is to determine the prevalence of periodontitis in patients with Lynch syndrome (LS) compared with reference prevalence estimates from the general population40.

研究概览

研究类型

观察性的

注册 (估计的)

25

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Milan、意大利、20132
        • IRCCS San Raffaele

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

概率样本

研究人群

All the subjects affected by LS, treated between the established study period, will be considered enrolled in the present study, as long as they meet the inclusion criteria. Patients will be anonymized by specific procedures explained in the following paragraphs. All records identifying the subject must be kept confidential and, to the extent permitted by the applicable laws and/or regulations, not be made publicly available.

Subjects with Lynch Syndrome (LS) will be identified and recruited through the Gastroenterology and Gastrointestinal Endoscopy Unit, where LS patients are routinely followed within dedicated surveillance programs.

A subset of these patients has also undergone dental and periodontal evaluation at the Dentistry Unit of IRCCS Ospedale San Raffaele as part of routine clinical care, independent from the present study.

描述

Inclusion Criteria:

  1. Age ≥18 years;
  2. All sexes eligible
  3. Established diagnosis of LS performed as part of clinical practice, with a germline pathogenic/likely pathogenic variant in one of the following genes: MLH1, MSH2, MSH6, PMS2, and EpCAM
  4. LS subjects undergoing surveillance gastrointestinal endoscopy according to clinical practice and international guidelines.
  5. Subjects underwent dental and periodontal examination

Exclusion Criteria:

  1. Age < 18 years;
  2. Absence of sufficient periodontal clinical or radiographic data to establish a periodontal diagnosis;
  3. Subjects affected by systemic, autoimmune, chronic inflammatory, neurological, or severe psychiatric disorders, or by any other clinical condition that may interfere with study participation or data interpretation
  4. Subjects with systemic conditions known to strongly affect periodontal status (e.g. uncontrolled diabetes, autoimmune inflammatory diseases, ongoing cancer therapy) were excluded to reduce major confounding factors that could independently alter periodontal outcomes.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Prevalence of periodontitis in Lynch Syndrome subjects.
大体时间:Retrospective assessment at study enrollment

Diagnosis of periodontitis

  • Interdental clinical attachment loss (CAL) at ≥2 non-adjacent teeth
  • Buccal/oral CAL ≥3 mm with pocketing >3 mm detectable at ≥2 teeth

Clinical attachment loss = CAL = Distance between the cementoenamel junction and the base of the periodontal pocket (tip of the periodontal probe)

Retrospective assessment at study enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2026年7月31日

研究完成 (估计的)

2026年7月31日

研究注册日期

首次提交

2026年5月12日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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