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

NCT ID: NCT06529588

Last Updated: 2024-07-31

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer Chronic Periodontitis Radiotherapy Side Effect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type RADIATION

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation

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

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Head and neck cancer patients after 6 irradiation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Maarif University College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed A. Al-Kubaisi, PhD

Role: STUDY_DIRECTOR

Al-Maarif University College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ahmed A. Al-Kubaisi

Ramadi, Al Anbar, Iraq

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iraq

References

Explore related publications, articles, or registry entries linked to this study.

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 BACKGROUND
PMID: 35304084 (View on PubMed)

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)

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.

Reference Type DERIVED
PMID: 39334335 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

suPAR as a potential biomarker

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.