suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients
- Conditions
- Radiotherapy; ComplicationsChronic PeriodontitisHead and Neck Cancer
- Interventions
- Radiation: Head and Neck cancer post-radiotherapy
- Registration Number
- NCT06481059
- Lead Sponsor
- Al-Maarif University College
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- A pathologically confirmed malignant neoplasm of HNC (derived from epithelial cells).
- Not having received radiation therapy previously.
- No distant metastasis.
- No history of salivary gland surgery (parotid, submandibular, or sublingual).
- A generally satisfactory physical condition with a performance score of 0 to 1 point and a planned survival period of more than a year and scores of 2 higher indicating increasing disability.
- Previous oral disease or salivary gland disease history.
- Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
- Refusal to participate in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Head and neck cancer post-radiotherapy Head and Neck cancer post-radiotherapy Head and neck cancer patients who received radiotherapy after six months. fractions no. \[(32-35 fractions) 5700-7000 Gy\] addition chemotherapy \[(cisplatin or cetuximab) (2-3 doses)\].
- Primary Outcome Measures
Name Time Method Measure of serum suPAR level at 6 months Measure of serum suPAR level in patients head and neck cancer who received radiotherapy
- Secondary Outcome Measures
Name Time Method Periodontal parameters measured at 6 month All periodontal parameters (Clinical attachment level, Gingival bleeding Index, Plaque index, and Periodontal pocket depth measures were performed manually using a millimeter periodontal probe in patients who received radiotherapy.
Trial Locations
- Locations (1)
Ahmed A. Al-Kubaisi
🇮🇶Ramadi, Anbar, Iraq