Periodontal Disease and Colorectal Cancer

NCT06799182 | Completed

• 1 other identifier: 0120-486/2021/6 PB in KRK
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
2. 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?

Conditions

Periodontal Diseases; Colorectal Carcinoma

Outcome Measures

Primary Outcomes (2)

• CRP levels

  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

  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

Study Arms (2)

Patients with colorectal cancer who recived periodontal treatment

EXPERIMENTAL

Patients with colorectal cancer were treated for periodontal disease based on the condition of their periodontal tissues.

Procedure: periodontal treatment

Patients with colorectal cancer who did not recived periodontal treatment

NO INTERVENTION

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.

Interventions

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.

Also known as: Biopsy of the intestinal mucosa for quantitative culture, samples of periodontal biofilm for quantitative culture

Patients with colorectal cancer who recived periodontal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• colorectal cancer, scheduled for surgical treatment
• consent to participate
• fiilled questionnaire
• Recorded CRP results at the first examination, after surgery, and at the first follow-up examination.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Institute of Oncology Ljubljana: collaborator
• Institute of microbiology and immunology, Slovenia: collaborator

Study Sites (1)

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

Ljubljana, Slovenija, 1000, Slovenia

Location

MeSH Terms

Conditions

Periodontal Diseases; Colorectal Neoplasms

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Dental Health Surveys; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Dentistry; Periodontics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Dentistry

Study Officials

• Rok Schara, associate professor, doctor of dental medicine

  University Medical Cneter Ljubljana, Division of Stomatology, Center of oral disease and periodontology,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 29, 2025
• Study Start: October 25, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 5, 2024
• Last Updated: January 29, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

SL (1)