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Assessment of Cytotoxicity, Genotoxicity

Assessment of Cytotoxicity, Genotoxicity in Exfoliated Buccal Mucosa Cells Following Exposure to OPG and CBCT Radiations: A Comparative Study Across Age Groups

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07330401
Enrollment
60
Registered
2026-01-09
Start date
2024-10-01
Completion date
2025-09-30
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytotoxicity, Dental X-Ray Exposure, Genotoxicity, Ionizing Radiation Exposure

Keywords

Buccal Mucosa Cells, Micronucleus Assay, Dental Radiography, Orthopantomogram (OPG), Cone Beam Computed Tomography (CBCT), Low-Dose Ionizing Radiation, Age-Related Radiosensitivity

Brief 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.

Interventions

None listed

Sponsors

Yaxin Wang
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)10 ±12 days after exposureMicronucleated buccal epithelial cells will be quantified using the Buccal Micronucleus Cytome Assay following Sarto et al. (1987) criteria. For each participant, 2,000 exfoliated buccal cells will be evaluated at two time points: 1. immediately before dental X-ray exposure, and 2. approximately 10 ± 2 days after exposure. The primary analysis will report the change in the number of micronucleated cells per 2,000 cells (post-pre difference). Micronuclei are identified based on size, morphology, staining characteristics, and separation from the main nucleus. Higher post-pre values indicate greater genotoxic response.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026