suPAR is a Potential Biomarker of in Chronic Periodontitis Through the Impact of Post-radiotherapy on HNCs Patients

NCT ID: NCT06481059

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-23

Brief Summary

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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

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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.

Conditions

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Head and Neck Cancer Chronic Periodontitis Radiotherapy; Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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 \[(cisplatin or cetuximab) (2-3 doses)\].

Head and Neck cancer post-radiotherapy

Intervention Type RADIATION

Head and Neck Cancer patients who received radiotherapy after 6 months

Interventions

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Head and Neck cancer post-radiotherapy

Head and Neck Cancer patients who received radiotherapy after 6 months

Intervention Type RADIATION

Other Intervention Names

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Head and neck cancer patients after 6 irradiation

Eligibility Criteria

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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.
Minimum Eligible Age

28 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Maarif University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed A. Al-Kubaisi, PhD

Role: STUDY_DIRECTOR

Al-Maarif University College

Maysam A. Ghazi, MSc

Role: STUDY_CHAIR

Al-Maarif University College

Nisreen S. Majeed, MSc

Role: STUDY_CHAIR

Al-Maarif University College

Ekram R. Aldelaimi, BDS

Role: STUDY_CHAIR

Department of Periodontology, Al-Anbar Health Directorate, Ministry of Health

Hamid H. Enezei, PhD

Role: STUDY_DIRECTOR

Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Anbar

Locations

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Ahmed A. Al-Kubaisi

Ramadi, Al Anbar, Iraq

Site Status

Countries

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Iraq

References

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Gasparoni LM, Alves FA, Holzhausen M, Pannuti CM, Serpa MS. Periodontitis as a risk factor for head and neck cancer. Med Oral Patol Oral Cir Bucal. 2021 Jul 1;26(4):e430-e436. doi: 10.4317/medoral.24270.

Reference Type RESULT
PMID: 33340075 (View on PubMed)

Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.

Reference Type RESULT
PMID: 35304084 (View on PubMed)

Other Identifiers

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suPAR as a biomarker

Identifier Type: -

Identifier Source: org_study_id

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