Periodontal DiseasesPD and CRCNCT06799182
Periodontal Disease and Colorectal Cancer
A study testing periodontal treatment in people with Periodontal Diseases and Colorectal Carcinoma, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Colorectal Carcinoma
- What is being tested?
- periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 25 Oct 2023to 5 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Center Ljubljana, Division of stomatology, Center for oral disease and periodontology
Ljubljana, Slovenija, 1000
About this study
Official title: 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:
Read more
- Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
- 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.
- Conditions
- Periodontal Diseases, Colorectal Carcinoma
- Being tested
- periodontal treatment
- Medical subject headings
- Periodontal Diseases, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatmentProcedure or surgery
Also called Biopsy of the intestinal mucosa for quantitative culture, samples of periodontal biofilm for quantitative culture
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From the first dental exam to the resective colon surgery at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start25 Oct 2023
- Primary completion30 Sep 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Oncology Ljubljana, Institute of microbiology and immunology, Slovenia
- Responsible party
- Sponsor
- Investigators
- Rok Schara, associate professor, doctor of dental medicine, Study director, University Medical Cneter Ljubljana, Division of Stomatology, Center of oral disease and periodontology,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799182
- Sponsor's protocol ID
- 0120-486/2021/6 PB in KRK
- Acronym
- PD and CRC
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Rebersak UP, Brecelj E, Schara R. The influence of periodontal disease and periodontal treatment on colorectal cancer. Radiol Oncol. 2025 Dec 16;59(4):589-596. doi: 10.2478/raon-2025-0025. eCollection 2025 Dec 1.
PubMed 40272186
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Periodontal Disease and Periodontal Treatment on Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06799182
- Acronym / sponsor ID
- PD and CRC / 0120-486/2021/6 PB in KRK
- Conditions
- Periodontal Diseases, Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Institute of Oncology Ljubljana, Institute of microbiology and immunology, Slovenia
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 29 Jan 2025 (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 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:
- Does periodontal treatment affect the levels of C-reactive protein in the blood of patients undergoing cancer treatment?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer who recived periodontal treatment | Experimental | Procedure: periodontal treatmentPatients with colorectal cancer were treated for periodontal disease based on the condition of their periodontal tissues. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 treatmentAlso: Biopsy of the intestinal mucosa for quantitative culture, samples of periodontal biofilm for quantitative cultureBased 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. | Procedure or surgery | Patients with colorectal cancer who recived periodontal treatment |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 40272186Rebersak UP, Brecelj E, Schara R. The influence of periodontal disease and periodontal treatment on colorectal cancer. Radiol Oncol. 2025 Dec 16;59(4):589-596. doi: 10.2478/raon-2025-0025. eCollection 2025 Dec 1.
- Individual participant dataSharing planned: Yes. 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
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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. This study is not recruiting at the moment.
Rok Schara, associate professor, doctor of dental medicine study director
University Medical Cneter Ljubljana, Division of Stomatology, Center of oral disease and periodontology,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing periodontal treatment in people with Periodontal Diseases and Colorectal Carcinoma, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 6 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: finished, as of the sponsor's last update on 29 Jan 2025. 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP levels (time frame: From the enrollment to the date of first documented progression at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06799182, which also lists 1 linked publication.
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 29 Jan 2025.