Periodontal DiseasesNCT07905859
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
An observational study of Periodontal Diseases and IBD, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontal Diseases, IBD, Dysbiosis
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2026to 23 Dec 2027
- How long will I take part?
- 3 Months
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients diagnosed with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, who also present with periodontitis and are eligible to receive periodontal therapy.
Who may be able to join
- clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
- periodontitis Stage III or IV
- BMI between 20 and 29 kg/m2
- free diet
- presence of at least 20 teeth
Who cannot join
- systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
- dietary allergies
- use of antibiotics or probiotics during the previous 30 days
- pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CIR Dental School
Turin, Turin, 10126
Mario Aimetti MA Prof., +39 0116331541, mario.aimetti@unito.it
About this study
Official title: Effects of Periodontal Therapy on Clinical Outcomes in Patients With Inflammatory Bowel Disease: A Prospective Observational Study
Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present observational prospective study is aimed at investigating the effect of conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.
- Conditions
- Periodontal Diseases, IBD, Dysbiosis, Inflammation
- Medical subject headings
- Periodontal Diseases, Dysbiosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical periodontal treatment NSPT | Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiome alpha diversity measured from stool samples at 3 months
Taxonomic and functional variation of gut bacteria after treatment
Measured: Baseline and 90 days
Secondary outcomes (5)
2. Changes in microbiome alpha diversity measured from saliva samples at 3 months
Taxonomic and functional variation of salivary bacteria after treatment
Measured: Baseline and 90 days
Changes in mean clinical attachment level (CAL) at 3 months
Variation in CAL after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Measured: Baseline and 90 days
Changes in periodontal pocket depth (PPD) at 3 months
Variation in PPD after therapy assessed using a millimetre marked manual periodontal probe at 6 sites per tooth element
Measured: Baseline and 90 days
Changes in full mouth bleeding score (FMBS) at 3 months
Variation in the percentage of bleeding sites after therapy assessed by gentle probing at 6 sites per tooth element
Measured: Baseline and 90 days
Changes in plasma inflammatory and immunological biomarkers
Changes in plasmatic levels of cytokines and other inflammatory biomarkers (IL-1, TNF-a, IL-6, CPR)
Measured: Baseline and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start3 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion23 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905859
- Sponsor's protocol ID
- IBD_Perio-Therapy
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Therapy on Clinical Outcomes in Patients With Inflammatory Bowel Disease: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07905859
- Acronym / sponsor ID
- IBD_Perio-Therapy
- Conditions
- Periodontal Diseases, IBD, Dysbiosis, Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 23 Dec 2027 (estimated)
- First posted
- 30 Oct 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.
Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present observational prospective study is aimed at investigating the effect of conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal treatment NSPT | – | –Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients diagnosed with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, who also present with periodontitis and are eligible to receive periodontal therapy.
Key inclusion criteria (5 listed)
- clinical and instrumental diagnosis of ulcerative colitis or Crohn's disease
- periodontitis Stage III or IV
- BMI between 20 and 29 kg/m2
- free diet
- presence of at least 20 teeth
Key exclusion criteria (4 listed)
- systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
- dietary allergies
- use of antibiotics or probiotics during the previous 30 days
- pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in microbiome alpha diversity measured from stool samples at 3 months
Time frame: Baseline and 90 days
Taxonomic and functional variation of gut bacteria after treatment
5 secondary outcomes
2. Changes in microbiome alpha diversity measured from saliva samples at 3 months
Time frame: Baseline and 90 days
Changes in mean clinical attachment level (CAL) at 3 months
Time frame: Baseline and 90 days
Changes in periodontal pocket depth (PPD) at 3 months
Time frame: Baseline and 90 days
Changes in full mouth bleeding score (FMBS) at 3 months
Time frame: Baseline and 90 days
Changes in plasma inflammatory and immunological biomarkers
Time frame: Baseline and 90 days
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Periodontal Diseases and IBD, run by University of Turin, Italy 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: looking for participants now, as of the sponsor's last update on 30 Oct 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 Mario Aimetti MA Prof. (+39 0116331541, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microbiome alpha diversity measured from stool samples at 3 months (time frame: Baseline and 90 days). 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 30 Oct 2026.