Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT06481059
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients
Sponsor:
Al-Maarif University College
Organization:
Study Overview
Official Title:
Soluble Urokinase Plasminogen Activator Receptor (suPAR) is a Potential Biomarker of Stage III-IV, Grade C Periodontitis Through the Impact of Post-radiotherapy on Head and Neck Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HNCs
Brief Summary:
This study aims to improve a soluble urokinase plasminogen activator receptor suPAR is a reliable biomarker of chronic periodontitis and may be replaced in patients with head and neck cancer post-radiotherapy (HNC post-RT).
Detailed Description:
The urokinase-type plasminogen activator receptor (uPAR) plays an essential function in leukocytes and endothelial homeostasis and, therefore, in the development of chronic periodontitis. The study enrolled 150 participants, 50 chronic periodontitis with head and neck cancer post radiotherapy (CP+HNC post-RT) patients, 50 chronic periodontitis (CP) without HNC patients, and 50 healthy controls. Clinical Attachment Loss (CAL), Probing Pocket Depth (PPD), Plaque Index (PI), and Gingival Bleeding Index (GBI) were recorded. An enzyme-linked immunosorbent assay (ELISA) was constructed to quantify serum (suPAR) levels. Stage and grade of periodontitis were stage III-IV, grade C in patients (CP+HNC post-RT), stage I-III, grade A/B in patients (CP without HNC), and absent in (healthy). Chronic periodontitis with HNC post-RT patients presented a significantly higher proportion of suPAR levels (506.7 pg/ml) compared to chronic periodontitis without HNC and healthy controls (423.08 pg/ml and 255.9 pg/ml), respectively. A significant positive correlation was found between serum suPAR levels and CAL, PPD, PI, and GBI in the periodontal disease groups. ROC results of suPAR (AUC=0.976 for CP+HNC post-RT, AUC=0.872 for CP without HNC). Hyposalivation appeared in patients (CP+HNC post-RT; 0.15 \[0.11-0.23\] ml/min, P=0.001) and (CP without HNC; 0.30 \[0.25-0.41\] ml/min, P=0.001), compared to healthy controls; 0.35 \[0.28- 0.54\] ml/min, P=0.001). The study showed a significant elevation in serum suPAR levels in CP+HNC post-RT patients compared to the CP without HNC and control groups.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: