Periodontal DiseasesNCT04790825
Periodontal Therapy on the Gut Microbiome of Inflammatory Bowel Disease
A study testing Full mouth scaling and root planing (FMSRP) in people with 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
- What is being tested?
- Full mouth scaling and root planing (FMSRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2021to 15 May 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
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 breast feeding
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CIR Dental School
Turin, 10126
Mario Aimetti, Prof., +39116331541, mario.aimetti@unito.it
About this study
Official title: Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial
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 randomised clinical trial is aimed at investigating the effect of intensive or 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
- Being tested
- Full mouth scaling and root planing (FMSRP)
- 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.
Full mouth scaling and root planing (FMSRP)Procedure or surgery
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Intensive periodontal treatment | Experimental | Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia. Receives: Procedure: Full mouth scaling and root planing (FMSRP) |
| Community-based periodontal care | Active comparator | Standard cycle of supragingival mechanical scaling and polishing. Receives: Procedure: Full mouth scaling and root planing (FMSRP) |
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)
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
Change of the inflammatory markers levels in plasma
Concentration of cytokines and biomarkers in plasma samples
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start2 May 2021
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- NCT04790825
- Sponsor's protocol ID
- IBD-perio project
- Status last verified
- Oct 2022
- First submitted
- 4 Feb 2021
- Last updated
- 2 Nov 2022
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive or Conventional Periodontal Therapy on the Gut Microbiome and Systemic Inflammation of Patients With Inflammatory Bowel Disease: a Single-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04790825
- Acronym / sponsor ID
- IBD-perio project
- Conditions
- Periodontal Diseases, IBD, Dysbiosis, Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 May 2021 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 10 Mar 2021 (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 randomised clinical trial is aimed at investigating the effect of intensive or conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive periodontal treatment | Experimental | Procedure: Full mouth scaling and root planing (FMSRP)Adjunctive full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia. |
| Community-based periodontal care | Active comparator | Procedure: Full mouth scaling and root planing (FMSRP)Standard cycle of supragingival mechanical scaling and polishing. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 breast feeding
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 |
|---|---|---|
| Full mouth scaling and root planing (FMSRP)Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours | Procedure or surgery | Community-based periodontal care, Intensive periodontal treatment |
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
Changes in microbiome alpha diversity measured from saliva samples at 3 months
Time frame: Baseline and 90 days
Change of the inflammatory markers levels in plasma
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full mouth scaling and root planing (FMSRP) in people with 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 2 Nov 2022.