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Completed

NCT Number: NCT06529588

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

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).

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Key information

Conditions

Head and Neck Cancer Chronic Disease Chronic Periodontitis Disease Attributes Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Radiation Injuries Radiotherapy Side Effect Stomatognathic Diseases Wounds and Injuries

Age range

28 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed A. Al-Kubaisi

Ramadi, Al-Anbar Governorate, 31001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiation

Radiation

HNCs patients who received radiotherapy was exposure (5700-7000 Gys) for fractions number (32-35) after 6 months

Other names: Head and neck cancer patients after 6 irradiation

Primary outcomes

  1. Measure of serum suPAR level

    Time frame: 6 months

    Measure of serum suPAR level in patients head and neck cancer who received radiotherapy

  2. Clinical Periodontal parameters measured

    Time frame: 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 outcomes

  1. Oral pH-saliva was measured

    Time frame: 6 month

    Oral pH-saliva collected from outcomes and measured pH-saliva by using pH-meter in patients who underwent radiotherapy.

Sponsors and collaborators

Lead sponsor

Al-Maarif University College

Other

Registry information

Official study 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

Acronym: HNCs

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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