Assessment of Cytotoxicity, Genotoxicity in Exfoliated Buccal Mucosa Cells Following Exposure to OPG and CBCT Radiations: A Comparative Study Across Age Groups
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
OPG,15-25 years old
CBCT,15-25 years old
OPG,40-50 years old
CBCT,40-50 years old
结局指标
主要结局
Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)
时间窗: 10 ±12 days after exposure
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: 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.
次要结局
未报告次要终点
研究者
Yaxin Wang
master
Universiti Sains Malaysia