PeriodontitisNCT04982302
Gut Microbial Changes After Periodontal Treatment
An observational study of Periodontitis and Dysbiosis, 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 to 75 years
- Conditions the study is for
- Periodontitis, Dysbiosis, Intestinal Disease
- What is being tested?
- Non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 1 Feb 2023
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: Study population will be consecutively selected among the patients diagnosed of Stage III-IV periodontitis at the Section of Periodontology of the C.I.R. Dental School of Turin.
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 30 days
- pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal 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 non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.
- Conditions
- Periodontitis, Dysbiosis, Intestinal Disease
- Being tested
- Non-surgical periodontal treatment
- Medical subject headings
- Periodontitis, Dysbiosis, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal treatmentProcedure or surgery
Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets
| 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 Receives: Procedure: Non-surgical periodontal treatment |
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: [Time Frame: Baseline and 90 days]
Secondary outcomes (4)
Changes in microbiome alpha diversity measured from saliva samples at 3 months
Taxonomic and functional variation of salivary bacteria after treatment
Measured: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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 posted29 Jul 2021
- Study start1 May 2021
- Primary completion1 Oct 2022
- Study completion1 Feb 2023
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
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
- NCT04982302
- Sponsor's protocol ID
- Perio-gut connection
- Status last verified
- Oct 2022
- First submitted
- 19 Jul 2021
- Last updated
- 18 May 2023
- 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 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT04982302
- Acronym / sponsor ID
- Perio-gut connection
- Conditions
- Periodontitis, Dysbiosis, Intestinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 29 Jul 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 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 non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical periodontal treatment NSPT | – | Procedure: Non-surgical periodontal treatmentSubgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets in 2 or 4 appointments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population will be consecutively selected among the patients diagnosed of Stage III-IV periodontitis at the Section of Periodontology of the C.I.R. Dental School of Turin.
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 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 |
|---|---|---|
| Non-surgical periodontal treatmentSubgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets | Procedure or surgery | Non-surgical periodontal treatment NSPT |
Primary outcome
Changes in microbiome alpha diversity measured from stool samples at 3 months
Time frame: [Time Frame: Baseline and 90 days]
Taxonomic and functional variation of gut bacteria after treatment
4 secondary outcomes
Changes in microbiome alpha diversity measured from saliva samples at 3 months
Time frame: [Time Frame: Baseline and 90 days]
Changes in mean clinical attachment level (CAL) at 3 months
Time frame: [Time Frame: Baseline and 90 days]
Changes in periodontal pocket depth (PPD) at 3 months
Time frame: [Time Frame: Baseline and 90 days]
Changes in full mouth bleeding score (FMBS) at 3 months
Time frame: [Time Frame: Baseline and 90 days]
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 18 May 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Periodontitis and Dysbiosis, 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: finished, as of the sponsor's last update on 18 May 2023. 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?
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?
Changes in microbiome alpha diversity measured from stool samples at 3 months (time frame: [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 18 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.