Periodontal Disease in Patients With Lynch Syndrome

NCT07600710 | Not Yet Recruiting

• 1 other identifier: CET79-2026
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lynch Syndrome; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Prevalence of periodontitis in Lynch Syndrome subjects.

  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

Interventions

periodontal charting for the diagnosis of periodontitis OTHER

No additional interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rotundo Roberto: lead

Study Sites (1)

IRCCS San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Professor Rotundo Roberto

CONTACT

0201751500; rotundo.roberto@hsr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

IT (1)