Condition category
Oral Health
Date applied
30/04/2020
Date assigned
06/05/2020
Last edited
23/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Liyana Ghazali

ORCID ID

Contact details

Faculty of Dentistry
UiTM Sungai Buloh
Jalan Hospital
Sungai Buloh
47000
Malaysia
+60 (0)139288100
liyaghazali@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

600-IRMI (5/1/6)

Study information

Scientific title

Effects of scanning parameters reduction in dental radiographs on quality and diagnostics performance of the images and cytotoxicity of nuclei

Acronym

Study hypothesis

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

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

Study design

Single-centre double-blind parallel-group trial randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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 names

Primary outcome measure

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
2. The presence of nuclear alterations (pyknosis, karyolysis, karyorrhexis and nuclear budding) of buccal mucosa smear was noted (yes/no), taken before the exposure to x-rays and 10 days after the x-rays

Secondary outcome measures

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)

Overall trial start date

01/03/2017

Overall trial end date

31/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant 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

Recruitment start date

01/02/2018

Recruitment end date

30/06/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

Universiti Teknologi MARA
Orthodontic Clinic Faculty of Dentistry Kampus Sungai Buloh Jalan Hospital
Sungai Buloh
47000
Malaysia

Sponsor information

Organisation

Universiti Teknologi MARA

Sponsor details

Faculty of Dentistry
UiTM Sungai Buloh
Jalan Hospital
Sungai Buloh
47000
Malaysia
+60 (0)361266555
liyaghazali@yahoo.com

Sponsor type

University/education

Website

http://www.uitm.edu.my/index.php/en

Funders

Funder type

University/education

Funder name

Universiti Teknologi MARA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The plan for this study is to divide the trial into two parts (two publications) where the first part will report the results regarding diagnostic performance and quality of the images. The second part will report the score of nuclei alterations of the buccal mucosa.

IPD sharing statement
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.

Intention to publish date

01/11/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.