Circulating Progenitor Cells Levels in Periodontal Disease Patients

Completed

• Conditions: Metabolic Disease
• Interventions: Other: Observation

• Registration Number: NCT04143568
• Lead Sponsor: University of Messina

Brief 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.

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.

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-11-30
• Status Verified: 2019-10
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-26
• Last Update Submitted: 2019-10-26
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Observation	Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease
Periodontitis	Observation	Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease

Primary Outcome Measures

Name	Time	Method
Evaluation of endothelial progenitor cells level	1 year	Changes of endothelial progenitor cells level

Trial Locations

Locations (1)

University of Messina; 🇮🇹 Messina, Italy