NCT05275127

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

February 8, 2022

Last Update Submit

April 6, 2023

Conditions

Cardiovascular DiseasesPeriodontal Diseases

Keywords

Periodontitis, GCF

Outcome Measures

Primary Outcomes (1)

  • Clinical attachment level reduction

    evaluation of millimeters reduction of clinical attachment level (CAL) after periodontal therapy

    1-year

Study Arms (2)

Q-SRP

Evaluation of changes of gingival crevicular fluid miRNA

Other: changes of gingival crevicular fluid miRNA

FM-SRP

Evaluation of changes of gingival crevicular fluid miRNA

Other: changes of gingival crevicular fluid miRNA

Interventions

changes of gingival crevicular fluid miRNAOTHER

Evaluation of changes of gingival crevicular fluid miRNA after periodontal treatment

FM-SRPQ-SRP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania

Catania, CT, 95124, Italy

Location

MeSH Terms

Conditions

Cardiovascular DiseasesPeriodontal DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Gaetano Isola

    Università degli Studi di Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 11, 2022

Study Start

March 14, 2022

Primary Completion

November 15, 2022

Study Completion

November 20, 2022

Last Updated

April 7, 2023

Record last verified: 2023-04

Locations

IT(1)