Salivary Redox Biomarkers and Oral HealthNCT07020078
Oral Health Condition Among a Group of Ionizing Radiation Field Workers
An observational study of Salivary Redox Biomarkers and Oral Health, run by Al-Mustansiriyah University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Salivary Redox Biomarkers and Oral Health
- What is being tested?
- Salivary redox biomarkers
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2025to 25 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Salivary Redox Biomarkers in Relation to Oral Health Condition Among a Group of Ionizing Radiation Field Workers
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.
- Being tested
- Salivary redox biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary redox biomarkersRadiation
Salivary redox biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline: the subjects must be fasting. up to two hours saliva collection
Secondary outcomes (3)
Salivary Malondialdehyde biomarker
Measure salivary malondialdehyde biomarker for all 90 subjects (computed tomography,x_ray and laboratory group) to see if the ionizing radiation effect on salivary Redox status in relation to oral health condition for workers in radiation field
Measured: Baseline:saliva collection for malondialdehyde . up to two hours fasting for all subjects.
Salivary 8_ hydroxy_deoxyguanosine biomarker
Measure salivary 8_hydroxy_deoxyguanosine biomarker for all 90 subjects (computed tomography,x_ray and laboratory group) to see if the ionizing radiation effect on salivary Redox status in relation to oral health condition for workers in radiation field
Measured: Baseline:saliva collection for 8_hydroxy_deoxyguanosine .up to two hours fasting for all subjects.
Salivary catalase biomarker
Measure salivary catalase biomarker for all 90 subjects (computed tomography,x_ray and laboratory group) to see if the ionizing radiation effect on salivary Redox status in relation to oral health condition for workers in radiation field
Measured: Baseline:saliva collection for catalase . up to two hours fasting for all subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Redox Biomarkers and Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihan munther hussien, Al-Mustansiriyah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020078
- Sponsor's protocol ID
- MustansiriyahU
- Status last verified
- Apr 2025
- First submitted
- 4 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Redox Biomarkers in Relation to Oral Health Condition Among a Group of Ionizing Radiation Field Workers
- ClinicalTrials.gov ID
- NCT07020078
- Acronym / sponsor ID
- MustansiriyahU
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salivary redox biomarkersSalivary redox biomarkers | Radiation | – |
Primary outcome
oral health status
Time frame: Baseline: the subjects must be fasting. up to two hours saliva collection
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.
3 secondary outcomes
Salivary Malondialdehyde biomarker
Time frame: Baseline:saliva collection for malondialdehyde . up to two hours fasting for all subjects.
Salivary 8_ hydroxy_deoxyguanosine biomarker
Time frame: Baseline:saliva collection for 8_hydroxy_deoxyguanosine .up to two hours fasting for all subjects.
Salivary catalase biomarker
Time frame: Baseline:saliva collection for catalase . up to two hours fasting for all subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Redox Biomarkers and Oral Health, run by Al-Mustansiriyah University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihan Munther Hussien, B.D.S (+9647719770649, jihanmunther@uomustansiriyah.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health status (time frame: Baseline: the subjects must be fasting. up to two hours saliva collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.