CClinicalTrials.gg
CompletedNCT04143568Updated Oct 29, 2019

Circulating Progenitor Cells Levels in Periodontal Disease Patients

An observational study in Metabolic Disease, sponsored by University of Messina. Completed at 1 site in Italy. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by University of Messina · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
167
Ages
20 Years to 70 Years
Sex
All
01

Study summary

Recently, a key role played in the ethiology of periodontitis has been highlighted by a subtype of stem cells derived from bone marrow, the circulating endothelial progenitor cells (EPCs). EPCs possess the ability to express surface antigens of endothelial and hematopoietic stem cells and to assist in maintaining vascular integrity and the repair mechanism of the endothelium. Among the main markers for the analysis of EPCs levels are CD34+, CD133+ and the kinase insert domain-containing receptor (KDR). CD34+ and CD133+ originate from hematopoietic stem cell antigens whereas KDR is a specific marker of endothelial cells. More specifically, CD34+ and CD133+/ KDR+ allows less mature and mature EPCs to be evaluated.

Read the detailed description

The aim of the present study was to investigate the association between endothelial progenitor cells (EPCs) levels subtype (CD133+/KDR+), in patients with periodontitis.

Furthermore, the objective was to determine if the periodontal status influenced CD133+/KDR+ levels.

02

Conditions studied

  • Metabolic Disease
03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 167 is above the median of 100 across 291 observational studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Messina is the lead sponsor of 53 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

79 healthy subjects, 88 patients with CP. Lipid profile and levels of CD133 and C-reactive protein (CRP) were evaluated.

Inclusion criteria

  • Presence of at least 16 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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
167 participants (actual)
Patient registry
No

Groups and cohorts

  • Control

    Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease

    Other: Observation

  • Periodontitis

    Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease

    Other: Observation

Interventions

  • OtherObservation

    Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease

06

What researchers measure

Primary outcomes

  1. Evaluation of endothelial progenitor cells level

    Changes of endothelial progenitor cells level

    Time frame: 1 year

07

Study locations

1 site
  • University of Messina
    Messina, 98125, Italy
08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04143568
Lead sponsor
University of Messina
Responsible party
Gaetano Isola, DDS, PhD (Junior Assistant Professor, University of Messina) — Principal investigator
First posted
Oct 29, 2019
Start date
Feb 1, 2016
Primary completion
Oct 30, 2018
Completion
Nov 30, 2018
Last update
Oct 29, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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