NCT06382753

Brief Summary

The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 20, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 20, 2024

Last Update Submit

April 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Bleeding on Probing

    Evaluation of bleeding on probing reduction

    5-years

Interventions

Patients were scored for their status of gingival inflammation using Gingival Index and Bleeding on Probing Scores

Eligibility Criteria

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

150 patients with diagnosed gingivitis

You may qualify if:

  • Diagnosis of Gingivitis

You may not qualify if:

  • Diagnosis of Periodontitis
  • Pregnancy
  • Systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

RECRUITING

MeSH Terms

Conditions

GingivitisPeriodontitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Gaetano Isola

    University of Catania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalia Leonardi

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 24, 2024

Study Start

April 20, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
1-year
Access Criteria
Pubmed
More information

Locations