Impact of Periodontal Treatment on Local miRNA Expression

April 6, 2023 updated by: Gaetano Isola, University of Catania

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • CT
      • Catania, CT, Italy, 95124
        • University of Catania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Q-SRP (no. 44 patients), FM-SRP (no. 45 patients)

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Q-SRP
Evaluation of changes of gingival crevicular fluid miRNA
Evaluation of changes of gingival crevicular fluid miRNA after periodontal treatment
FM-SRP
Evaluation of changes of gingival crevicular fluid miRNA
Evaluation of changes of gingival crevicular fluid miRNA after periodontal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical attachment level reduction
Time Frame: 1-year
evaluation of millimeters reduction of clinical attachment level (CAL) after periodontal therapy
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

November 20, 2022

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 215/21/PO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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