Periodontal Disease and Colorectal Cancer (PD and CRC)

January 22, 2025 updated by: University Medical Centre Ljubljana

The Influence of Periodontal Disease and Periodontal Treatment on Colorectal Cancer

The aim of this interventional study is to determine the impact of periodontal disease and periodontal treatment on patients with colorectal cancer.

The main questions were:

  1. Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
  2. Can the investigators isolate periodontal pathogenic bacteria Fusobacterium nucleatum and Porphyromonas gingivalis from the mucosa of cancerous colon tissue using the method of quantitative culture?

The investigators will compare the levels of C-reactive protein in the blood of patients undergoing treatment for colorectal cancer who have received periodontal treatment with patients who have not received periodontal treatment. CRP levels will be measured during the first examination with the oncological surgeon, on the first and second day after the surgical procedure, and during the first follow-up with the oncological surgeon.

Additionally, the investigators collected samples of cancerous colon mucosa from 10 participants for the attempt to isolate F. nucleatum and P. gingivalis using the quantitative culture method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
    • Slovenija
      • Ljubljana, Slovenija, Slovenia, 1000
        • University Medical Center Ljubljana, Division of stomatology, Center for oral disease and periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • colorectal cancer, scheduled for surgical treatment
  • consent to participate

Additional inclusion Criteria fot the control group:

  • fiilled questionnaire
  • Recorded CRP results at the first examination, after surgery, and at the first follow-up examination.

Exclusion Criteria:

  • under 18 years old
  • periodontal treatment in the past 12 months
  • antibiotic therapy in the last 3 months
  • edentulism
  • advanced stage cancer, scheduled for palliative care
  • chemotherapy or radiotherapy prior to surgical procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with colorectal cancer who recived periodontal treatment
Patients with colorectal cancer were treated for periodontal disease based on the condition of their periodontal tissues.
Procedure: periodontal treatment
Based on the results of the dental examination and the diagnosis of the periodontal tissue condition according to the new classification of periodontal disease, we performed appropriate non-surgical treatment of periodontal disease, provided oral hygiene instruction, and took a biofilm sample from the deep periodontal pocket. We then collected a sample of the altered mucosa during bowel surgery for colorectal cancer and conducted a microbiological investigation using quantitative culture to compare the presence of Fusobacterium nucleatum and Porphyromonas gingivalis in the pariodontal pocket and altered intestinal mucosa.
Other Names:
  • Biopsy of the intestinal mucosa for quantitative culture
  • samples of periodontal biofilm for quantitative culture
No Intervention: Patients with colorectal cancer who did not recived periodontal treatment
Due to ethical concerns, we selected patients who had completed cancer therapy before the start of our study for the control group, and who met the inclusion criteria based on the completed questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRP levels
Time Frame: From the enrollment to the date of first documented progression at 16 weeks
Measurement of CRP levels in the blood of patients with colorectal cancer at the first examination by the oncological surgeon, on the first and second day after colon resection, and at the first follow-up examination by the oncological surgeon.
From the enrollment to the date of first documented progression at 16 weeks
The proportion of Fusobacterium nucleatum and Porphyromonas gingivalis
Time Frame: From the first dental exam to the resective colon surgery at 2 weeks
Using quantitative culture for detection of periodontal bacteria Fusobacterium nucleatum and Porphyromonas gingivalis in the cancer altered intestinal musoca and comparing it with the status in the periodontal pocket
From the first dental exam to the resective colon surgery at 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Collaborators

Institute of Oncology Ljubljana
Institute of microbiology and immunology, Slovenia

Investigators

  • Study Director: Rok Schara, associate professor, doctor of dental medicine, University Medical Cneter Ljubljana, Division of Stomatology, Center of oral disease and periodontology,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2023

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-486/2021/6 PB in KRK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

sex, age, clinical diagnosis and location of colorectal cancer, histological diagnosis of the cancer, stage of cancer, BMI, Smoker or not, possible concomitant systemic diseases

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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