Effects of reducing the parameters on dental x-ray machine on image quality and cell toxicity
| ISRCTN | ISRCTN98755331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98755331 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 600-IRMI (5/1/6) |
| Sponsor | Universiti Teknologi MARA |
| Funder | Universiti Teknologi MARA |
- Submission date
- 30/04/2020
- Registration date
- 06/05/2020
- Last edited
- 24/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
A dental x-ray is essential to aid diagnosis and treatment planning. It is important to give clinicians information that cannot be obtained through physical examination. The increased use of x-rays increases radiation exposure. This has raised concern as exposure to radiation can cause cell damage and alterations which can increase the risk of developing oral cancer. One of the ways to reduce radiation exposure is by reducing the parameters available on the x-ray machine which are tube potential (kV) and tube current (mA). Although it is ideal and easy to reduce the parameters, the value and quality of the images must not be compromised. Thus, the aim of this study is to study the effect of reducing x-ray parameters on the diagnostic value and quality of the images. This study also looks at the presence of nuclear alterations after exposure to dental x-rays when the radiation dose is reduced.
Who can participate?
Patients aged 18 - 35 who attend the orthodontic clinic and were indicated for DPT and LC as part of routine assessment before starting orthodontic treatment
What does the study involve?
Patients are randomly allocated into two groups, control and intervention. The control group receive a standard radiation dose by setting x-rays machine in auto-mode. The intervention group receive a reduced radiation dose by decreasing the parameters on the x-ray machine. A buccal mucosa (the inner lining of the lips and cheeks) smear is taken using a brush and participants have a routine orthodontic assessment. Participants are then sent for a dental x-ray. They are called back to the clinic 10 days after the x-rays for a second buccal mucosa smear.
What are the possible benefits and risks of participating?
The participants in the intervention group may benefit from receiving a lower radiation dose. The risks include slight discomfort when the buccal mucosa smear is taken.
Where is the study run from?
Universiti Teknologi MARA (Malaysia)
When is the study starting and how long is it expected to run for?
March 2017 to August 2019
Who is funding the study?
Universiti Teknologi MARA (Malaysia)
Who is the main contact?
Dr Noraina Hafizan Norman
norainanorman@gmail.com
Contact information
Public
Faculty of Dentistry
UiTM Sungai Buloh
Jalan Hospital
Sungai Buloh
47000
Malaysia
| Phone | +60 (0)139288100 |
|---|---|
| liyaghazali@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre double-blind parallel-group trial randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effects of scanning parameters reduction in dental radiographs on quality and diagnostics performance of the images and cytotoxicity of nuclei |
| Study objectives | 1. There is no difference in image quality and diagnostic performance between standard and reduced scanning parameters. 2. There is a reduction in nuclei cytotoxicity when scanning parameters is reduced. |
| Ethics approval(s) | Approved 05/07/2017, Uitm Research Ethics Committee (Universiti Teknologi MARA, Aras 3, Bangunan Wawasan, 40450 Shah Alam, Selangor, Malaysia; +60 (0)355448069; recsecretariat@uitm.edu.my), ref: REC/232/17 |
| Health condition(s) or problem(s) studied | Digital dental panoramic tomogram and lateral cephalogram radiation exposure |
| Intervention | Participants were randomized 1:1 into control and intervention groups. The control group received standard scanning parameters as prescribed by the manufacturer by setting the radiographic machine in auto mode. Participants in the intervention group received reduced scanning parameters where the dental panoramic tomogram (DPT) was reduced by 60% and lateral cephalogram (LC) by 30%. All the participants were exposed to radiation once for each modality. Buccal mucosa smears were taken before radiation exposure and 10 days after the radiation exposure. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Diagnostic performance of the images assessed using detection of anatomical landmarks (25 landmarks on dental panoramic tomogram and 35 landmarks on lateral cephalogram) after the x-rays were taken |
| Key secondary outcome measure(s) |
Quality of the images assessed using a five-point rating scale after the x-rays taken (1= excellent, 2= more than adequately presented, 3= adequately presented 4= barely adequately presented, 5= inadequately presented) |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | All |
| Target sample size at registration | 38 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Adults 18-35 years old 2. Indicated for dental panoramic tomogram and lateral cephalogram 3. Fit and healthy 4. Normal body mass index (BMI) 18.5 - 25 |
| Key exclusion criteria | 1. Patients contraindicated for radiographic examination 2. Pregnant 3. Occupational health exposure 4. Facial and skeletal abnormalities 5. Bone disease 6. Smoking or has stopped less than 6 months 7. Oral diseases including ulcers in the past 2 weeks |
| Date of first enrolment | 01/02/2018 |
| Date of final enrolment | 30/06/2019 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Faculty of Dentistry
Kampus Sungai Buloh
Jalan Hospital
Sungai Buloh
47000
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | For this study, the participants’ level data are the x-ray images (DPT and LC) and slides containing buccal mucosa smears. All images are stored online on UiTM’s Integrated Dental Records Management System (iDERMS) (https://dentistry.uitm.edu.my/v2/index.php/en/) and can only be assessed by clinician in-charged using UiTM’s intranet system. X-rays and any patients’ records are medico-legal documents thus the access is restricted. Prior to the commencement of the study, informed consent was obtained from patients. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2021 | 24/06/2021 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/06/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
23/09/2020: The intention to publish date was changed from 14/05/2020 to 01/11/2020.
04/05/2020: Trial's existence confirmed by Uitm Research Ethics Committee.
