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Completed

NCT Number: NCT06799182

Periodontal Disease and 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.

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Key information

Conditions

Periodontal Diseases Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Rectal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Ljubljana, Division of stomatology, Center for oral disease and periodontology

Ljubljana, Slovenija, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Periodontal Treatment

Procedure

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

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Institute of Oncology Ljubljana
  • Institute of microbiology and immunology, Slovenia

Registry information

Official study title

The Influence of Periodontal Disease and Periodontal Treatment on Colorectal Cancer

Acronym: PD and CRC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

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.

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