Periodontal Disease in Patients With Lynch Syndrome

ConditionsLynch Syndrome Periodontal Disease

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorRotundo Roberto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

periodontal charting for the diagnosis of periodontitis
Other intervention
No additional interventions

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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)

Time frame

Retrospective assessment at study enrollment

Sponsors and contacts

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Rotundo Roberto

Lead sponsor

IRCCS San Raffaele

Sponsor institution

Source ClinicalTrials.gov

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