Effectiveness of an audiovisual method for oral hygiene instruction in orthodontic patients wearing braces for correcting the position of teeth
| ISRCTN | ISRCTN14146882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14146882 |
| Secondary identifying numbers | UKM PPI/111/8/JEP-2017-575 |
- Submission date
- 27/01/2022
- Registration date
- 04/02/2022
- Last edited
- 20/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Orthodontic patients undergo braces treatment for at least 20 months. It is important to maintain good oral hygiene during this period. Therefore, effective oral hygiene instruction must be provided before the treatment starts to prevent future problems such as gingivitis and demineralization of enamel. However, little is known on the duration of knowledge retention of patients after receiving oral hygiene instruction as well as whether an instruction that was given through audiovisual can improve patients’ compliance.
This study aimed to assess the effectiveness of an audiovisual method in delivering instruction to orthodontic patients.
Who can participate?
Patients undergoing orthodontic treatment
What does the study involve?
After the placement of the braces, the patient was given instruction either in audiovisual method or written and verbal method. The instruction was given again as a reinforcement after one month, three months and six months during follow-ups. Then patient's oral hygiene status and knowledge retention were assessed.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Orthodontic Clinic, Faculty of Dentistry, Universiti Kebangsaan Malaysia
When is the study starting and how long is it expected to run for?
June 2017 to May 2019
Who is funding the study?
Orthodontic Clinic, Faculty of Dentistry, Universiti Kebangsaan Malaysia
Who is the main contact?
Umi Mardhiyyah Mat Ali, drumi@usm.my
Contact information
Principal Investigator
PT 739
Kampung Wakaf Stan
Kota Bharu
16150
Malaysia
 ORCID ID |
0000-0002-8733-9888 |
|---|---|
| Phone | +60 199126841 |
| drumi@usm.my |
Study information
| Study design | Single-centre a two-arm parallel randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | 41024 PIS.pdf |
| Scientific title | Effects of audiovisual oral hygiene instruction on orthodontic patients: a randomized controlled trial |
| Study objectives | That there is a significant difference in oral health status between audiovisual and written & verbal instruction methods. |
| Ethics approval(s) | Approved 15/09/2017, Research Ethics Committee, The National University of Malaysia (1st Floor, Clinical Block, Hospital Canselor Tunku Muhriz, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur Malaysia, +603-91455046/5048; sepukm@ukm.edu.my), ref: UKM PPI/111/8/JEP-2017-575 |
| Health condition(s) or problem(s) studied | Oral hygiene of orthodontic patients |
| Intervention | This clinical trial included 60 orthodontic patients ages ranged from 13 to 40 years old. They were randomized into two groups which are audiovisual method (AV) (n=30) and written and verbal method (WV) (n=30). After placement of the fixed appliances, oral hygiene instruction was given, and at one, three, and six-month followed up as reinforcement. Patients' oral health status was measured using plaque and gingiva indices before placement of fixed appliance as a baseline and at one, three and six months followed up. Randomization and Blinding: 60 patients receiving fixed appliance treatment were divided into two groups by simple randomization. The audiovisual group (AV) and the written and verbal group (WV) were randomly assigned to 60 pieces of paper, with a sample size of 30 in each group. During patient selection, a researcher's assistant randomly selected papers from an opaque box. The data was gathered and analysed by an examiner who was blinded to the patients' method of instruction during the trial. |
| Intervention type | Behavioural |
| Primary outcome measure | Oral health status measured using plaque and gingiva indices before placement of fixed appliance as a baseline and at one, three, and six months follow up |
| Secondary outcome measures | Oral hygiene status measured using a questionnaire at one, three and six months |
| Overall study start date | 20/06/2017 |
| Completion date | 21/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Patient ongoing fixed orthodontic treatment. 2. No previous orthodontic treatment 3. Age range 13 - 30 years old 4. Can fluently speak and read in Malay language |
| Key exclusion criteria | 1. Patient with any syndromic diseases & cleft lip and palate 2. Patient using any kind of dental prosthesis |
| Date of first enrolment | 10/11/2017 |
| Date of final enrolment | 20/06/2018 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
Sponsor information
University/education
Faculty Of Dentistry
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
| Phone | +60 392897741 |
|---|---|
| dfdental@ukm.edu.my | |
| Website | http://www.ukm.my |
"ROR" |
https://ror.org/01590nj79 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Universiti Kebangsaan Malaysia (UKM), Universiti Kebangsaan Malaysia (UKM), Malaysia, ukminsta, Universiti Kebangsaan Malaysia - UKM, Universiti Kebangsaan Malaysia (Malaysia), University Kebangsaan (Malaysia), UKM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 27/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Umi Mardhiyyah Mat Ali, drumi@usm.my, type of data: oralhygiene status report, data are available now, request by email, suitable for statistical analysis. Consent was obtained from patient, data will be anonymised |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 04/02/2022 | No | Yes | ||
| Results article | 01/09/2020 | 04/02/2022 | Yes | No |
Additional files
Editorial Notes
20/12/2022: Internal review.
04/02/2022: Trial's existence confirmed by Research Ethics Committee, The National University of Malaysia.
