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Trial registered on ANZCTR


Registration number
ACTRN12621001639819
Ethics application status
Approved
Date submitted
8/10/2021
Date registered
30/11/2021
Date last updated
30/11/2021
Date data sharing statement initially provided
30/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of tooth decay development around braces bonded to the tooth with two different adhesive materials.
Scientific title
Comparison of white spot lesion development around orthodontic brackets bonded with resin-modified glass ionomer and resin composite cements.
Secondary ID [1] 305486 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
White spot lesions 323867 0
Early enamel decay 324128 0
Dental caries 324129 0
Condition category
Condition code
Oral and Gastrointestinal 321383 321383 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bonding orthodontic brackets with resin-modified glass ionomer cement (RMGIC).

This study involves assessment of the maxillary and mandibular anterior teeth only. After randomisation, two quadrants (Q1&3 or Q2&4) will have orthodontic brackets bonded with RMGIC using the following protocol:
1. Clean enamel surface with pumice
2. Condition enamel surface for 60 seconds with 5% sodium hypochlorite, followed by thorough rinsing
3. Etch enamel for 15 seconds using 37% phosphoric acid, following by thorough rinsing
4. Apply Fuji Ortho LC (GC Australasia) to the bracket and light cure according to the manufacturer’s instructions

Overall duration of procedure was 5-10 minutes, and administered by either a registered orthodontist or orthodontic postgraduate student. Brackets were bonded to the teeth for a minimum of 6 months; after this, the brackets may or may not be repositioned as part of routine orthodontic treatment. There was no strategy to monitor adherence as the investigator could not be present for the bonding appointment.
Intervention code [1] 321894 0
Prevention
Comparator / control treatment
Bonding orthodontic brackets with resin composite cement (RC).

In the remainder quadrants (Q1&3 or Q2&4), orthodontic brackets are bonded with RC on the maxillary and mandibular teeth. The following protocol is used:
1. Clean enamel surface with pumice
2. Etch enamel for 15 seconds using 37% phosphoric acid, following by thorough rinsing
3. Apply Transbond MIP (3M Unitek) and air dry for 2-5 seconds
4. Apply Transbond XT Light Cure Adhesive to the bracket and light cure according to the manufacturer’s instructions

Overall duration of procedure was 5-10 minutes, and administered by either a registered orthodontist or orthodontic postgraduate student. Brackets were bonded to the teeth for a minimum of 6 months; after this, the brackets may or may not be repositioned as part of routine orthodontic treatment. There was no strategy to monitor adherence as the investigator could not be present for the bonding appointment.
Control group
Active

Outcomes
Primary outcome [1] 329160 0
To determine the prevalence of white spot lesion development around orthodontic brackets bonded with resin-modified glass ionomer cement compared to bonding with resin composite cement.

This will be done by using the ICDAS-II caries detection index.
Timepoint [1] 329160 0
T0: before orthodontic bracket bonding
T1: immediately after orthodontic bracket bonding of full dentition completed
T2: at least 6 months after orthodontic bracket bonding
Secondary outcome [1] 401687 0
To compare the visual characteristics of white spot lesions that have developed around orthodontic brackets bonded with resin-modified glass ionomer cement vs. resin composite cement.

This will be done by taking standardised digital photographs, converting them into greyscale images, and evaluating the mean grey value of white spot lesions in the 'ImageJ' software program.
Timepoint [1] 401687 0
T0: before orthodontic bracket bonding
T1: immediately after orthodontic bracket bonding of full dentition completed
T2: at least 6 months after orthodontic bracket bonding

Eligibility
Key inclusion criteria
1. All permanent anterior teeth present
2. All types of malocclusions
3. Treatment plan could involve orthognathic surgery or extractions
4. Consent/assent by the patient and/or parent to participate in the study
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Severe malposition of anterior teeth preventing brackets to be placed at the initial appointment
2. History of orthodontic treatment
3. Presence of early enamel demineralisation in the form of WSLs
4. Presence of developmental defects of enamel, such as hypomineralisation, hypoplasia or amelogenesis imperfecta

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of the experimental and control quadrants within each participant was concealed by placing the allocation into individually sealed envelopes that were to be opened at the bonding appointment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated table was applied for block randomisation to randomise quadrants within each participant into the resin-modified glass ionomer cement and resin composite cement groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
A computer-generated table was applied for block randomisation to randomise participants into the resin-modified glass ionomer cement and resin composite groups. Allocation of the experimental and control quadrants was concealed by placing the allocation into individually sealed envelopes that were to be opened at the bonding appointment. The investigators and patients were blinded to the allocation. It was not possible for the operator to be blinded.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary outcome:
- The differences in the sum of ICDAS-II scores between the resin-modified glass ionomer (RMGIC) and resin composite cement (RC) groups were assessed within the individual participant. Statistical differences across the participants were assessed using a Wilcoxon signed-rank test due to a highly skewed distribution of the total scores.
- Classification of participants into low cariogenic or cariogenic groups was performed. The within-patient differences of the sum of ICDAS-II scores between teeth receiving RMGIC and RC were evaluated. A Mann-Whitney U test was used to determine if there was a statistical difference between low cariogenic or cariogenic plaque subgroups.

Secondary outcome:
- Repeated measurements of the mean grey value for all white spot lesions (WSLs) were made one week apart after initial measurements. An intra-class correlation (ICC) and Bland-Altman plot were calculated for T0 and T2 measurements.
- To test the difference in absolute and proportional change in mean grey value of WSLs between the RMGIC and RC groups, a Mann-Whitney U test was applied.
- A Wilcoxon signed-rank test was applied to test for differences in the absolute and proportional change in mean grey value between WSL and sound enamel areas.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/08/2018
Date of last participant enrolment
Anticipated
Actual
15/10/2020
Date of last data collection
Anticipated
Actual
18/05/2021
Sample size
Target
54
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20700 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 35501 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 309843 0
Charities/Societies/Foundations
Name [1] 309843 0
The Stanley Jacobs Trust for Orthodontic Research
Country [1] 309843 0
Australia
Funding source category [2] 309850 0
Charities/Societies/Foundations
Name [2] 309850 0
Australian Society of Orthodontists Foundation for Research and Education
Country [2] 309850 0
Australia
Funding source category [3] 309851 0
University
Name [3] 309851 0
Melbourne Dental School Postgraduate Research Grant
Country [3] 309851 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 310880 0
Individual
Name [1] 310880 0
Associate Professor Paul Schneider
Address [1] 310880 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country [1] 310880 0
Australia
Other collaborator category [1] 282015 0
Individual
Name [1] 282015 0
Dr Teesit Teeramongkolgul
Address [1] 282015 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country [1] 282015 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309583 0
The University of Melbourne - Medicine and Dentistry Human Ethics Sub-Committee
Ethics committee address [1] 309583 0
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Ethics committee country [1] 309583 0
Australia
Date submitted for ethics approval [1] 309583 0
Approval date [1] 309583 0
24/04/2018
Ethics approval number [1] 309583 0
1750604

Summary
Brief summary
This within-patient, split-mouth randomised controlled trial aims to determine whether orthodontic bracket bonding with resin-modified glass ionomer cement (RMGIC) to sodium hypochlorite (NaOCl) conditioned enamel will affect the development of white spot lesions (WLSs) compared to brackets bonded with resin composite cement (RC). It is hypothesised that bonding with RMGIC after pre-treatment with NaOCl will reduce the prevalence of WSLs around orthodontic brackets compared to RC.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114670 0
Dr Alan Tran
Address 114670 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country 114670 0
Australia
Phone 114670 0
+61 430538651
Fax 114670 0
Email 114670 0
[email protected]
Contact person for public queries
Name 114671 0
Alan Tran
Address 114671 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country 114671 0
Australia
Phone 114671 0
+61 430538651
Fax 114671 0
Email 114671 0
[email protected]
Contact person for scientific queries
Name 114672 0
Alan Tran
Address 114672 0
Melbourne Dental School
The University of Melbourne
720 Swanston Street
Carlton VIC 3053
Country 114672 0
Australia
Phone 114672 0
+61 430538651
Fax 114672 0
Email 114672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13481Informed consent form    382903-(Uploaded-08-10-2021-10-37-34)-Study-related document.pdf
13483Ethical approval    382903-(Uploaded-19-11-2021-14-01-19)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.