Cardiovascular DiseasesNCT05275127
Impact of Periodontal Treatment on Local miRNA Expression
An observational study of Cardiovascular Diseases and Periodontal Diseases, run by University of Catania at 1 site in Italy.
Trial summary
To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Periodontal Diseases
- What is being tested?
- changes of gingival crevicular fluid miRNA
- How many people
- 89 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2022to 20 Nov 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Q-SRP (no. 44 patients), FM-SRP (no. 45 patients)
Who may be able to join
- Presence of at least 15 teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL)
- ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Who cannot join
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
- Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Gingival Crevicular Fluid miRNA Changes After Periodontal Treatment.
To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent.
Read the detailed description
The patients selected for the study were divided into 2 groups: group 1 (FM-SRP), group 2 (Q-SRP). Any selected subject underwent anamnestic and periodontal examination, blood and GCF sampling. MiRNA in the GCF was extracted through a commercially available kit and then measured carrying out real-time quantitative polymerase chain reaction (RT-PCR).
- Conditions
- Cardiovascular Diseases, Periodontal Diseases
- Being tested
- changes of gingival crevicular fluid miRNA
- Keywords
- Periodontitis, GCF
- Medical subject headings
- Cardiovascular Diseases, Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changes of gingival crevicular fluid miRNAOther
Evaluation of changes of gingival crevicular fluid miRNA after periodontal treatment
| Study group | Role | What they receive |
|---|---|---|
| Q-SRP | Evaluation of changes of gingival crevicular fluid miRNA Receives: Other: changes of gingival crevicular fluid miRNA | |
| FM-SRP | Evaluation of changes of gingival crevicular fluid miRNA Receives: Other: changes of gingival crevicular fluid miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-7a-5p, miR-21-5p, miR-100-5p, miR-125b-5p and miR-200b-5p changes
Changes in miR-7a-5p, miR-21-5p, miR-100-5p, miR-125b-5p and miR-200b-5p after treatment
Measured: 1-year
Clinical attachment level reduction
evaluation of millimeters reduction of clinical attachment level (CAL) after periodontal therapy
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start14 Mar 2022
- Primary completion15 Nov 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, University of Catania
- Investigators
- Gaetano Isola, Principal investigator, Università degli Studi di Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275127
- Sponsor's protocol ID
- 215/21/PO
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gingival Crevicular Fluid miRNA Changes After Periodontal Treatment.
- ClinicalTrials.gov ID
- NCT05275127
- Acronym / sponsor ID
- 215/21/PO
- Conditions
- Cardiovascular Diseases, Periodontal Diseases
- Keywords
- Periodontitis, GCF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 11 Mar 2022 (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.
To assess the impact of Fill Mouth Scaling and Root planing or Quadrant Scaling and Root planing gingival crevicular fluid (GCF) levels of miRNA 7a-5p, miRNA 21-3p, miRNA 21-5p, miRNA 100-5p, miRNA 125-5p, miRNA 200b-3p and miRNA 200b-5p and their correlation with periodontitis extent.
Detailed description
The patients selected for the study were divided into 2 groups: group 1 (FM-SRP), group 2 (Q-SRP). Any selected subject underwent anamnestic and periodontal examination, blood and GCF sampling. MiRNA in the GCF was extracted through a commercially available kit and then measured carrying out real-time quantitative polymerase chain reaction (RT-PCR).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q-SRP | – | Other: changes of gingival crevicular fluid miRNAEvaluation of changes of gingival crevicular fluid miRNA |
| FM-SRP | – | Other: changes of gingival crevicular fluid miRNAEvaluation of changes of gingival crevicular fluid miRNA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Q-SRP (no. 44 patients), FM-SRP (no. 45 patients)
Key inclusion criteria (5 listed)
- Presence of at least 15 teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL)
- ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Key exclusion criteria (6 listed)
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
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 |
|---|---|---|
| changes of gingival crevicular fluid miRNAEvaluation of changes of gingival crevicular fluid miRNA after periodontal treatment | Other | FM-SRP, Q-SRP |
Primary outcome
miR-7a-5p, miR-21-5p, miR-100-5p, miR-125b-5p and miR-200b-5p changes
Time frame: 1-year
Changes in miR-7a-5p, miR-21-5p, miR-100-5p, miR-125b-5p and miR-200b-5p after treatment
Clinical attachment level reduction
Time frame: 1-year
evaluation of millimeters reduction of clinical attachment level (CAL) after periodontal therapy
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided. all collected IPD, all IPD that underlie results in a publication
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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.
Gaetano Isola principal investigator
Università degli Studi di Catania
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 Cardiovascular Diseases and Periodontal Diseases, run by University of Catania 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 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 16 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?
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?
miR-7a-5p, miR-21-5p, miR-100-5p, miR-125b-5p and miR-200b-5p changes (time frame: 1-year). 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?
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 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.