Estimation of (suPAR) in Chronic Periodontitis With Post-radiotherapy on HNCs Patients

Completed

• Conditions: Head and Neck Cancer; Chronic Periodontitis; Radiotherapy Side Effect
• Interventions: Radiation: Radiation

• Registration Number: NCT06529588
• 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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-01-09
• Study Completion: 2023-10-23
• Study First Submitted: 2024-06-18
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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.

Exclusion Criteria

• 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	Radiation	Head and Neck cancer patients who received radiotherapy (32-35 fractions) exposure (5700-7000 Gys) addition chemotherapy (cisplatin or cetuximab (2-3 dosages).

Primary Outcome Measures

Name	Time	Method
Measure of serum suPAR level	6 months	Measure of serum suPAR level in patients head and neck cancer who received radiotherapy
Clinical Periodontal parameters measured	6 months	Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.

Secondary Outcome Measures

Name	Time	Method
Oral pH-saliva was measured	6 month	Oral pH-saliva collected from outcomes and measured pH-saliva by using pH-meter in patients who underwent radiotherapy.

Trial Locations

Locations (1)

Ahmed A. Al-Kubaisi; 🇮🇶 Ramadi, Anbar, Iraq