GenotoxicityNCT07330401
Assessment of Cytotoxicity, Genotoxicity
An observational study of Genotoxicity and Cytotoxicity, run by Yaxin Wang at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Genotoxicity, Cytotoxicity, Ionizing Radiation Exposure
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Malaysia1 site
universiti Sains Malaysia hospital
Kota Bharu, Kelantan, 25000
About this study
Official title: 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.
- Keywords
- Buccal Mucosa Cells, Micronucleus Assay, Dental Radiography, Orthopantomogram (OPG), Cone Beam Computed Tomography (CBCT), Low-Dose Ionizing Radiation, Age-Related Radiosensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OPG,15-25 years old | Not described | |
| CBCT,15-25 years old | Not described | |
| OPG,40-50 years old | Not described | |
| CBCT,40-50 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 ±12 days after exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Oct 2024
- Primary completion1 Jul 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaxin Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaxin Wang, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330401
- Sponsor's protocol ID
- Universiti Sains Malaysia wang
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cytotoxicity, Genotoxicity in Exfoliated Buccal Mucosa Cells Following Exposure to OPG and CBCT Radiations: A Comparative Study Across Age Groups
- ClinicalTrials.gov ID
- NCT07330401
- Acronym / sponsor ID
- Universiti Sains Malaysia wang
- Keywords
- Buccal Mucosa Cells, Micronucleus Assay, Dental Radiography, Orthopantomogram (OPG), Cone Beam Computed Tomography (CBCT), Low-Dose Ionizing Radiation, Age-Related Radiosensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yaxin WangUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OPG,15-25 years old | – | – |
| CBCT,15-25 years old | – | – |
| OPG,40-50 years old | – | – |
| CBCT,40-50 years old | – | – |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Genotoxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genotoxicity and Cytotoxicity, run by Yaxin Wang at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: Change in micronucleated buccal epithelial cells measured by the Buccal Micronucleus Cytome Assay (MN per 2,000 cells) (time frame: 10 ±12 days after exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.