CompletedNot Applicable

Assessment of Cytotoxicity, Genotoxicity

Malaysia60 participantsStarted 2024-10-01

Plain-language summary

Goal: The goal of this observational study is to evaluate the genotoxic and cytotoxic effects of OPG and CBCT on exfoliated buccal mucosal cells Main question: Does CBCT cause greater genotoxic and cytotoxic effects on buccal mucosal cells compared with OPG? Buccal epithelial cells were gently exfoliated from participants scheduled to undergo OPG or CBCT imaging. Samples were collected twice-immediately before exposure and again 10-12 days afterward. All participants provided written informed consent prior to inclusion in the study.

Who can participate

Age range

15 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Underwent routine dental imaging using OPG or CBCT (no additional radiation for research purposes). Age 15-25 years or 40-50 years at the time of enrolment. Able and willing to provide written informed consent (or consent from a legal guardian for minors). Agreed to provide pre-exposure and follow-up buccal epithelial cell samples. Exclusion Criteria: History of systemic diseases, including but not limited to leukemia, lymphoma, rheumatic disorders, or diabetes mellitus. Prior exposure to head-and-neck radiotherapy, immunosuppressive drugs, or cytotoxic medications. Presence of active infectious diseases or acute/chronic inflammatory conditions at the time of enrolment. Clinically visible oral pathological lesions, including mucosal abnormalities, gingivitis, or periodontitis. Use of removable intra-oral prostheses or appliances (e.g., dentures, orthodontic appliances). Engagement in smoking, alcohol consumption, or betel-nut chewing. Diagnostic or therapeutic X-ray exposure within the preceding 3 months. Previous or current oral mucosal diseases, including oral lichen planus, recurrent aphthous stomatitis, oral candidiasis, HSV infection, leukoplakia, oropharyngeal carcinoma, mucous membrane pemphigoid, or pemphigus vulgaris. Presence of persistent local irritants, including ill-fitting dental prostheses, sharp teeth/restorations, chemical irritation (acidic foods, alcohol-based mouthwash), or recurrent thermal injury.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)

Timeframe: 10 ±12 days after exposure

Trial details

NCT IDNCT07330401

SponsorYaxin Wang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-01

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