- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05275127
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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