Condition category
Oral Health
Date applied
19/10/2020
Date assigned
02/11/2020
Last edited
06/11/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
After the completion of orthodontic treatment, patients undergo a retention phase to maintain the results. During this phase, an orthodontic retainer is used. The retainer is worn 24 hours a day except when eating, drinking, brushing and playing sports. Without adequate cleaning, retainers can accumulate plaque and bacteria, leading to gingival (gum) inflammation and disease. A study showed that saliva quantity and composition is affected during orthodontic treatment. A variety of alternative cleaning agents have been discussed of which were mostly tested on acrylic orthodontic appliances and prostheses. To date, however, few studies have been performed to investigate the effects of cleaning agents on thermoplastic retainers and changes in the oral environment. The aim of this study is to assess the effectiveness of different cleaning agents for retainers.

Who can participate?
Adults over the age of 18 who are fitted with a thermoplastic retainer

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group are asked to clean their retainers using tap water. Those in the second group are asked to clean using a provided toothpaste and the third group are asked to clean using Retainer Brite to clean their retainers. A detailed explanation, demonstration and written instructions will be provided. The study lasts 6 months in total. Participants saliva will be assessed during retainer fit and at 3 months and 6 months follow up. Participants also complete an assessment form during the 3 months and 6 months follow up appointment.

What are the possible benefits and risks of participating?
There is no risk of participating in this study as it is carried out during the regular follow up of treatment. The results of this study will benefit individuals, researchers, and the community with the advancement of knowledge and orthodontic practice. It will also show if the different cleaning agents influence saliva parameters and the patients’ experience. It will also be beneficial to practitioners to know the best cleaning agent with the least amount of bacteria which will support the recommendations for cleaning methods of orthodontic retainers in the future.

Where is the study run from?
Universiti Teknologi Mara (UiTM) (Malaysia)

When is the study starting and how long is it expected to run for?
September 2019 to August 2021

Who is funding the study?
Universiti Teknologi Mara (UiTM) (Malaysia)

Who is the main contact?
1. Dr Iman binti Azmuddin
imanazmuddin@gmail.com
2. Dr Saraswathy Devi Sinniah
saraswathy6153@uitm.edu.my

Trial website

Contact information

Type

Public

Primary contact

Dr Iman Azmuddin

ORCID ID

https://orcid.org/0000-0002-2216-5047

Contact details

Faculty of Dentistry
Universiti Teknologi Mara (UiTM)
Sungai Buloh
47000
Malaysia
+60 (0)132580852
imanazmuddin@gmail.com

Type

Scientific

Additional contact

Dr Saraswathy Devi Sinniah

ORCID ID

http://orcid.org/0000-0003-1481-2424

Contact details

Faculty of Dentistry
Universiti Teknologi Mara (UiTM
Sungai Buloh
47000
Malaysia
+60 (0)361266100
saraswathy6153@uitm.edu.my

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Effectiveness of thermoplastic retainer cleansing agents and patient-reported outcome: a randomized controlled trial

Acronym

ETRCA

Study hypothesis

1. There is no significant difference in the presence of Mutans Streptococci (MS) between three cleansing agents
2. There is no significant difference in salivary parameters in unstimulated saliva
3. There is no significant difference in patient-reported outcome with different cleansing agents

Ethics approval

Approved 29/09/2020, UiTM Research Ethics Committee (Research Management Centre (RMC), Office of Deputy Vice Chancellor (Research & Innovation) Universiti Teknologi MARA, Level 3, Bangunan Wawasan, 40450 Shah Alam, Selangor, Malaysia; +60 (0)355442049; recsecretariat@uitm.edu.my), ref: 600- TNCP1(5/1/6)

Study design

Single-center interventional single-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

Prevention of caries in patients wearing a thermoplastic retainer

Intervention

This trial is a randomized controlled trial with three parallel arms. Patients will be randomly allocated to either group A (tap water), group B (toothpaste) or group C (Retainer Brite). The list of randomisation will be generated using SPSS statistical software.

A detailed explanation, demonstration and written instructions will be provided. The study lasts 6 months in total. Participants saliva will be assessed during the retainer fitting and at 3 months and 6 months follow up. Participants also complete an assessment form during the 3 months and 6 months follow up appointment.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Bacterial count of Mutans Streptococci (MS) measured using colony counting method at retainer fit, 3 months and 6 months post retainer fit

Secondary outcome measures

1. Saliva parameters (hydration, viscosity, pH and quantity) during retention measured using time and visual assessment of the transparency, volume and pH test strip indicator at retainer fit, 3 months and 6 months post retainer fit
2. Patient-reported outcome measured using assessment form at 3 months and 6 months post retainer fit

Overall trial start date

27/09/2019

Overall trial end date

31/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients fitted with thermoplastic retainer
2. Over 18 years old
3. Caries free
4. Healthy periodontal status

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Pregnant
2. Patients on medication
3. Smokers
4. Patients with systematic disease
5. Prosthetic tooth in retainer

Recruitment start date

15/11/2020

Recruitment end date

15/02/2021

Locations

Countries of recruitment

Malaysia

Trial participating centre

Universiti Teknologi Mara
Department of Orthodontics Faculty of Dentistry Jalan Hospital
Sungai Buloh
47000
Malaysia

Sponsor information

Organisation

Universiti Teknologi MARA

Sponsor details

Faculty of Dentistry
Sungai Buloh Campus
Shah Alam
40450
Malaysia
+60 (0)361265000
recsecretariat@uitm.edu.my

Sponsor type

University/education

Website

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

Funders

Funder type

University/education

Funder name

Institute of Research Management and Innovation, Universiti Teknologi MARA

Alternative name(s)

Institute of Research Management & Innovation, IRMI, UiTM

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

Malaysia

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/08/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/11/2020: Uploaded protocol (not peer reviewed) Version n/a, 20 October 2020. 23/10/2020: Trial's existence confirmed by UiTM Research Ethics Committee.