NCT07020078

Brief Summary

The goal of this study is to test the effect of ionizing radiation on salivary Redox status among a group of ionizing radiation workers by measuring salivary biomarkers(malondialdehyde,8\_hydroxy\_deoxyguanosine and catalase) and measuring oral health condition by plaque index. 90 male subjects will be enrolled in this study between 30\_40 years old worked in Baghdad teaching hospital ,30 subjects exposed from computed tomography department ,30 subjects exposed from x\_ray department and 30 subjects unexposed from laboratory department in the same hospitals. The method of the study is taking unstimulated saliva sample from the subjects and oral health measure.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 25, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
Last Updated

June 13, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

May 4, 2025

Last Update Submit

June 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • oral health status

    Changes in the clinical periodontal parameter (Plaque index ) To determine the patients' plaque index, their dental plaque thickness was evaluated by probing the mesial, distal, buccal, and palatal surfaces of all teeth using a Williams periodontal probe. The individual's plaque index was determined by summing the values obtained for each tooth and calculating the averages.Silness \& Löe (Silness \& Löe,1964) reference values were taken as a basis The Plaque Index (PI) scores each site on a 0 to 3 scale Score 0 : No plaque is in the area adjacent to the gingiva. Score 1: There is a plaque in the form of a thin film on the gingival margin. Score 2: There is a visible plaque in the gingival pocket and gingival margin. Score 3: There is a dense plaque in the gingival pocket and on the gingival margin.

    Baseline: the subjects must be fasting. up to two hours saliva collection

Secondary Outcomes (3)

  • Salivary Malondialdehyde biomarker

    Baseline:saliva collection for malondialdehyde . up to two hours fasting for all subjects.

  • Salivary 8_ hydroxy_deoxyguanosine biomarker

    Baseline:saliva collection for 8_hydroxy_deoxyguanosine .up to two hours fasting for all subjects.

  • Salivary catalase biomarker

    Baseline:saliva collection for catalase . up to two hours fasting for all subjects.

Interventions

Salivary redox biomarkers

Eligibility Criteria

Age30 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male workers in radiation field from 30\_40 years old who exposed to radiation for 5\_10 years and compare them with male workers in laboratory at age 30\_40 years

You may qualify if:

  • male, 30\_40 years ,no history of systemic disease, no medical treatment taken at least 3 months before sampling and the subjects are exposed to radiation 5\_ 10 years

You may not qualify if:

  • subjects with medical history , subjects are taken medications during last 3 months , the subjects are exposed to radiation less than 5 years or more than 10 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jihan Munther Hussien, B.D.S

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

May 4, 2025

First Posted

June 13, 2025

Study Start

June 25, 2025

Primary Completion

July 25, 2025

Study Completion

August 25, 2025

Last Updated

June 13, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share