Assessment of Cytotoxicity, Genotoxicity

Yaxin Wang

Status: Completed

Conditions: Ionizing Radiation Exposure; Dental X-Ray Exposure; Cytotoxicity; Genotoxicity

Study type: Observational

Funder types: Other

Identifiers

NCT07330401

Universiti Sains Malaysia wang

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 4 patient groups

OPG,15-25 years old

CBCT,15-25 years old

OPG,40-50 years old

CBCT,40-50 years old