PeriodontitisNCT06261515
Multi-omics Analysis of Oral-gut Microbial Profiles
A study testing Active periodontal treatment in people with Periodontitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Active periodontal treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2024to 15 Feb 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 90 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, PA, +390116331541, mario.aimetti@unito.it
About this study
Official title: Multi-omics Multi-specimens Evaluation of Oral-gut-systemic Profiles in Patients With Stage III-IV Periodontitis Pre- and After-therapy
Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.
- Conditions
- Periodontitis
- Being tested
- Active periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active periodontal treatmentProcedure or surgery
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets; periodontal surgery if needed (residual probing pocket depths ≥ 6 mm).
| Study group | Role | What they receive |
|---|---|---|
| Conventional periodontal treatment | Experimental | Periodontal treatment of stage III-IV periodontitis patients according to the guideline recommendation from the European Federation of Periodontology will be provided. Receives: Procedure: Active periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbial profile measured in stool samples
Taxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics
Measured: Baseline and 90 days
Changes in oral microbial profile measured in saliva samples
Taxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics
Measured: Baseline and 90 days
Changes in oral microbial profile measured in subgingival plaque samples
Taxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics
Measured: Baseline and 90 days
Secondary outcomes (3)
Changes in oral-gut metabolome measured in stool samples
Untargeted metabolic variation of oral-gut environment after treatment
Measured: Baseline and 90 days
Changes in oral-gut miRNAome measured in stool samples
miRNA variation of oral-gut environment after treatment
Measured: Baseline and 90 days
Metabolic plasma changes
Concentration of IL-1β, IL-6, IL-10, TNF-α, INF-γ, glucose, and cortisol released in plasma
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 posted15 Feb 2024
- Study start15 Feb 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 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
- NCT06261515
- Sponsor's protocol ID
- Perio-gut PRIN
- Status last verified
- May 2024
- First submitted
- 29 Jan 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics Multi-specimens Evaluation of Oral-gut-systemic Profiles in Patients With Stage III-IV Periodontitis Pre- and After-therapy
- ClinicalTrials.gov ID
- NCT06261515
- Acronym / sponsor ID
- Perio-gut PRIN
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 15 Feb 2024 (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 is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that periodontal treatment may influence the multi-omics profile on the oral-gut-systemic axis. 70 patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary, subgingival plaque, plasma and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conventional periodontal treatment | Experimental | Procedure: Active periodontal treatmentPeriodontal treatment of stage III-IV periodontitis patients according to the guideline recommendation from the European Federation of Periodontology will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 90 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 |
|---|---|---|
| Active periodontal treatmentSubgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets; periodontal surgery if needed (residual probing pocket depths ≥ 6 mm). | Procedure or surgery | Conventional periodontal treatment |
Primary outcome
Changes in gut microbial profile measured in stool samples
Time frame: Baseline and 90 days
Taxonomic variation of gut bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in saliva samples
Time frame: Baseline and 90 days
Taxonomic variation of salivary bacteria concentration after treatment assessed through shotgun metagenomics
Changes in oral microbial profile measured in subgingival plaque samples
Time frame: Baseline and 90 days
Taxonomic variation of subgingival bacteria concentration after treatment assessed through shotgun metagenomics
3 secondary outcomes
Changes in oral-gut metabolome measured in stool samples
Time frame: Baseline and 90 days
Changes in oral-gut miRNAome measured in stool samples
Time frame: Baseline and 90 days
Metabolic plasma changes
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 31 May 2024.
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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 Active periodontal treatment in people with Periodontitis, 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 4 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 31 May 2024. 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?
Contact Mario Aimetti, PA (+390116331541, 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 gut microbial profile measured in stool samples (time frame: Baseline and 90 days). The study lists 3 primary outcomes in all. 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 31 May 2024.