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

NCT06529588 | Completed

• 1 other identifier: suPAR as a potential biomarker
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Cancer; Chronic Periodontitis; Radiotherapy Side Effect

Keywords

Chronic Periodontitis; Head and Neck Cancer; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Measure of serum suPAR level

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

  6 months

• Clinical Periodontal parameters measured

  Periodontal parameters included (CAL, PI, GBI, PPD) measured by using a millimeter periodontal probe in patients with head and neck cancer who received radiotherapy.

  6 months

Secondary Outcomes (1)

• Oral pH-saliva was measured

  6 month

Study Arms (1)

Head and neck cancer post-radiotherapy

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

Radiation: Radiation

Interventions

Radiation RADIATION

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

Also known as: Head and neck cancer patients after 6 irradiation

Head and neck cancer post-radiotherapy

Eligibility Criteria

• Age: 28 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study was n=26 nasopharyngeal tumors (n=20 nonkeratinizing and n=6 keratinizing carcinomas), (n=6 oropharyngeal squamous cell carcinoma, SCC), (n=8 Laryngeal cancer), (n=6 tongue cancer), and (n=4 primary malignancies of unclear origin). Twenty-eight of the patients (or 56%) had a concomitant systemic therapy (2-3 doses) of cisplatin or cetuximab in addition to radiotherapy. Chronic periodontitis patients without HNCs included: Patients' average ages ranged from 28 to 65 years, with 40 (80%) of them being male. More than half of them had a history of smoking, with 31 (62%) and 5 (10) of them having used alcohol. A control group was used periodontally healthy as a controlled study, the mean age was 40.12 years (min-max: 29-60 years).

You may qualify if:

• 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.

You may not qualify if:

• Previous oral disease or salivary gland disease history.
• Definitive diagnosis of multiple sclerosis, xerostomia, or systemic disease.
• Refusal to participate in the study.

Sponsors & Collaborators

• Al-Maarif University College: lead

Study Sites (1)

Ahmed A. Al-Kubaisi

Ramadi, Al-Anbar Governorate, 31001, Iraq

Location

Related Publications (3)

• 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.

  PMID: 35304084 BACKGROUND

• 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.

  PMID: 33340075 RESULT

• Al-Kubaisi AA, Ghazi MA, Majeed NS, Aldelaimi ER, Enezei HH. 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. BMC Oral Health. 2024 Sep 27;24(1):1144. doi: 10.1186/s12903-024-04801-w.

  PMID: 39334335 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Chronic Periodontitis; Radiation Injuries

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Ahmed A. Al-Kubaisi, PhD

  Al-Maarif University College

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 31, 2024
• Study Start: September 1, 2022
• Primary Completion: January 9, 2023
• Study Completion: October 23, 2023
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

IR (1)