Effects of thermoplastic dental retainer cleansing agents on the retainer's physical properties and price analysis

ISRCTN	ISRCTN70450905
DOI	https://doi.org/10.1186/ISRCTN70450905

Submission date: 20/04/2025
Registration date: 05/05/2025
Last edited: 02/05/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
After the completion of orthodontic treatment, when the braces are to be taken off, a patient needs to wear a retainer. The retainers are custom-made appliances used to maintain the teeth's position, and the type of retainer provided in this study is a thermoplastic retainer. The retainer needs to be worn 24 hours except during mealtimes, toothbrushing and sports activities. Without adequate cleansing, retainers can lead to the accumulation of plaque and bacteria in the mouth, and this may also affect the physical form of the retainer. Several studies have investigated the stability and physical form of thermoplastic retainer after being exposed to different cleansers that are commonly used in orthodontic care, but mostly in a laboratory setting. To date, however, very few studies have been performed in a real clinical scenario to investigate the effects of cleansing agents on the physical properties of thermoplastic retainer. This study aims to study the effects of thermoplastic retainer cleansing agents on the physical properties of thermoplastic retainer and to determine the price range of the cleansing agents.

Who can participate?
Adult orthodontic patients who have completed treatment with a fixed appliance and will be fitted with a thermoplastic retainer.

What does the study involve?
Patients who had their braces removed at the UiTM Sungai Buloh dental clinics were informed about the study's goals and procedures. Those who agreed to join were given details about the study and randomly assigned to use one of three cleaning methods: toothpaste, Retainer Brite®, or tap water. They received instructions on dental care and retainer cleaning through demonstrations and WhatsApp messages in English and Malay. Participants were provided with a dental kit and a retainer diary link, along with videos showing proper cleaning techniques. They were reviewed every 6 weeks, and after 6 months, their used retainers were collected for lab evaluation. New impressions were taken to create custom-fitted retainers for nighttime use.

What are the possible benefits and risks of participating?
Information obtained from this research will benefit the individuals, researchers, institutions and community for the advancement of knowledge and future practice. The results of this research will show the most effective cleansing agent for patients wearing thermoplastic retainers. Besides, it will show us if cleansing agents may affect the physical properties of thermoplastic retainer and finally, to determine the price range of the cleansing agents through market survey.

There is no harm expected from this study in any aspect, physically, mentally or psychologically. Participants will only need to follow specific instructions given to cleanse and wear their retainer and attend review appointments every 6 weeks, till the 6-month follow-up.

Where is the study run from?
Universiti Teknologi MARA (UiTM), Faculty of Dentistry, Malaysia

When is the study starting and how long is it expected to run for?
February 2024 to March 2027

Who is funding the study?
Investigator initiated and funded.

Who is the main contact?
Dr Wan Salmah binti Yang Mohsin, 2024657312@student.uitm.edu.my, wsym27@gmail.com

Contact information

Dr Wan Salmah Yang Mohsin
Public, Scientific, Principal Investigator

Faculty of Dentistry
Universiti Teknologi Mara (UiTM)
Sungai Buloh
47000
Malaysia

Phone	+60122394943
Email	2024657312@student.uitm.edu.my

Dr Saraswathy Devi Sinniah
Public, Scientific

Faculty of Dentistry UITM
Jalan Hospital
Sungai Buloh, Selangor
47000
Malaysia

ORCID ID	0000-0003-1481-2424
Phone	+60355448069
Email	saraswathy6153@uitm.edu.my

Dr Nik Mukhriz Nik Mustapha
Public, Scientific

Faculty of Dentistry UITM
Jalan Hospital
Sungai Buloh, Selangor
47000
Malaysia

ORCID ID	0000-0002-6095-993X
Phone	+60355448069
Email	nikmukhriz@uitm.edu.my

Dr Nur Aliana Hidayah Mohamed
Public, Scientific

Faculty of Dentistry UITM
Jalan Hospital
Sungai Buloh, Selangor
47000
Malaysia

ORCID ID	0000-0002-4662-9862
Phone	+60355448069
Email	alianahidayah@uitm.edu.my

Study information

Study design	Single-centre interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	University/medical school/dental school
Study type	Other, Quality of life, Efficacy
Participant information sheet	47209_PIS.pdf
Scientific title	Effects of thermoplastic retainer cleansing agents on the polymer physical properties and price analysis: a randomised controlled trial
Study acronym	Nil known
Study objectives	Thermoplastic retainer cleansing agents (Toothpaste, Retainer Brite, and Tap water) have no significant difference on the effects of physical properties of polymer retainer. There is no significant difference in price analysis between the thermoplastic retainer cleansing agents (Toothpaste, Retainer Brite and Tap water).
Ethics approval(s)	Approved 07/10/2024, Universiti Teknologi MARA (UiTM) Research Ethics Committee (Aras 3, Bangunan Wawasan, Shah Alam, Selangor, 40450, Malaysia; +60355448069; recsecretariat@uitm.edu.my), ref: REC/10/2024 (PG/MR/489)
Health condition(s) or problem(s) studied	An effective method to cleanse the thermoplastic retainer among debonded orthodontic patients
Intervention	This is a single-centered, randomised controlled trial study which will involve orthodontic patients who have completed their orthodontic treatment, in the Faculty of Dentistry, UITM Campus Sungai Buloh. The conduct of the study will comply with the CONSORT 2010 guidelines for reporting data. The patients will be randomly allocated into the study groups by following the block randomisation in Microsoft Excel. Numbers will be written in sequence based on the total number of samples on each card and then inserted into the opaque sealed envelopes. Patient's treatment allocation will be based on the number on the envelope. During debond sessions, patients will be recruited and selected based on inclusion and exclusion criteria. The patient will be randomly allocated to 3 groups of cleansing agents (Toothpaste, Retainer Brite and Tapwater). Upon issuing the retainers, thorough instructions will be given in terms of dental care and the thermoplastic retainer. A chairside demo and written instructions will be provided as well via WhatsApp, detailing the assigned cleaning intervention in both English and Malay. The participants will be provided with the dental kit and a link for the retainer diary. A verified MPEG file of pre-recorded video will be shared to demonstrate to patients on how to brush their teeth and clean their retainer correctly. These videos were according to the 3 assigned cleansing procedures. Patients will be reviewed every 6 weeks. After a period of 6 months, the used retainers will be collected for laboratory evaluation. New alginate impressions will be obtained to create a new set of retainers for the patient. The retainer will be custom-fitted the next day to facilitate its use throughout nighttime wear.
Intervention type	Other
Primary outcome measure	1. Changes in translucency and colour of retainer polymer are measured using a spectrophotometer at baseline and 6 months 2. Changes in surface roughness of the retainer polymer are measured using a profilometer at baseline and 6 months 3. Changes in the flexural strength of the retainer polymer are measured using a universal testing machine at baseline and 6 months 4. Comparison of prices for the thermoplastic retainer cleansing agents (Toothpaste, Retainer Brite, and Tap water) is measured using a monthly price survey. The prices for cleanser products, including over-the-counter, health sectors and virtual through official online purchasing websites, such as Amazon, Shopee and Lazada.
Secondary outcome measures	Surface roughness of the retainer polymer is measured by qualitative imaging using scanning electron microscopy (SEM) at baseline and 6 months
Overall study start date	07/02/2024
Completion date	19/03/2027

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Orthodontic patients who have completed treatment with a fixed appliance and are to be fitted with a thermoplastic retainer 2. Patients aged 18 and above
Key exclusion criteria	1. Patients who require a combination of orthodontic and orthognathic surgery 2. Medically compromised or patients who are taking any medication. 3. Patient with cognitive impairment that could affect the comprehension and behaviour 4. Smoker
Date of first enrolment	01/05/2025
Date of final enrolment	10/02/2026

Locations

Countries of recruitment

Malaysia

Study participating centres

Orthodontic Postgraduate Clinic

Faculty of Dentistry UiTM, Sungai Buloh
Jalan Hospital
Sungai Buloh, Selangor
47000
Malaysia

Orthodontic Specialist Clinic

Faculty of Dentistry UiTM, Sungai Buloh
Jalan Hospital
Sungai Buloh, Selangor
47000
Malaysia

Sponsor information

Universiti Teknologi MARA
University/education

ARAS 3, Bangunan Wawasan
Shah Alam
40450
Malaysia

Phone	+60355442794
Email	recsecretariat@uitm.edu.my
Website	https://uitm.edu.my
"ROR"	https://ror.org/05n8tts92

Funders

Funder type

Other

Investigator initiated and funded

No information available

UNIVERSITI TEKNOLOGI MARA

No information available

Results and Publications

Intention to publish date	26/03/2028
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The data-sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Malay and English		02/05/2025	No	Yes

Additional files

47209_PIS.pdf: Malay and English

Editorial Notes

22/04/2025: Study's existence confirmed by the Universiti Teknologi MARA (UiTM) Research Ethics Committee