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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 25000
      • universiti Sains Malaysia hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 15-25 years and 40-50 years undergoing routine dental radiographic examination (OPG or CBCT), with follow-up buccal cell sampling for cytogenetic analysis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
OPG,15-25 years old
CBCT,15-25 years old
OPG,40-50 years old
CBCT,40-50 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)	Micronucleated 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: immediately before dental X-ray exposure, and; 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.	10 ±12 days after exposure

Collaborators and Investigators

• Sponsor: Yaxin Wang

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): July 1, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Buccal Mucosa Cells; Micronucleus Assay; Dental Radiography; Orthopantomogram (OPG); Cone Beam Computed Tomography (CBCT); Low-Dose Ionizing Radiation; Age-Related Radiosensitivity
• Other Study ID Numbers: Universiti Sains Malaysia wang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No