Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07600710

Periodontal Disease in Patients With Lynch Syndrome

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years;
  • All sexes eligible
  • 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
  • LS subjects undergoing surveillance gastrointestinal endoscopy according to clinical practice and international guidelines.
  • Subjects underwent dental and periodontal examination

Exclusion criteria

  • Age < 18 years;
  • Absence of sufficient periodontal clinical or radiographic data to establish a periodontal diagnosis;
  • 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
  • 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.

Treatment and study plan

periodontal charting for the diagnosis of periodontitis

Other

No additional interventions

Primary outcomes

  1. Prevalence of periodontitis in Lynch Syndrome subjects.

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Rotundo Roberto

CONTACT

[email protected]

0201751500

Sponsors and collaborators

Lead sponsor

Rotundo Roberto

Other

Registry information

Official study title

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

Acronym: SMILy_25

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.