Lynch SyndromeSMILy_25NCT07600710
Periodontal Disease in Patients With Lynch Syndrome
An observational study of Lynch Syndrome and Periodontal Disease, run by Rotundo Roberto at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lynch Syndrome, Periodontal Disease
- What is being tested?
- periodontal charting for the diagnosis of periodontitis
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Lynch Syndrome, Periodontal Disease
- Being tested
- periodontal charting for the diagnosis of periodontitis
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal charting for the diagnosis of periodontitisOther
No additional interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Retrospective assessment at study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rotundo Roberto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rotundo Roberto, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600710
- Sponsor's protocol ID
- CET79-2026
- Acronym
- SMILy_25
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Disease in Patients With Lynch Syndrome: a Retrospective Observational, Monocentric Case-control Study
- ClinicalTrials.gov ID
- NCT07600710
- Acronym / sponsor ID
- SMILy_25 / CET79-2026
- Conditions
- Lynch Syndrome, Periodontal Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rotundo RobertoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal charting for the diagnosis of periodontitisNo additional interventions | Other | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Lynch Syndrome
RecruitingPhase 2
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
T Cells, Colorectal Cancer
Recruiting
FITting Non-invasive Tests in Lynch Syndrome Surveillance
Colorectal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Prostate Cancer
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lynch Syndrome and Periodontal Disease, run by Rotundo Roberto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Rotundo Roberto (0201751500, rotundo.roberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of periodontitis in Lynch Syndrome subjects. (time frame: Retrospective assessment at study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.