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Trial registered on ANZCTR


Registration number
ACTRN12617000925347
Ethics application status
Approved
Date submitted
11/10/2016
Date registered
27/06/2017
Date last updated
2/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the oral microorganisms between patients being treated with orthodontic brackets or aligners.
Scientific title
Difference in the oral microbiota of patients being treated with clear aligners and brackets: a clinical trial
Secondary ID [1] 290309 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
White spot lesions 300564 0
Gingivitis 300565 0
Condition category
Condition code
Oral and Gastrointestinal 300422 300422 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
Clear orthodontic aligners (Invisalign) to move teeth.

Test subjects- 60 participants will be treated orthodontically using Invisalign aligners. The aligners are to be worn 22 hours per day. Plaque samples will be taken and analysed prior to the start of treatment and at 6 months of treatment. Presence of white spot tooth lesions and gingivitis will be assessed at these 2 time periods.

The aligners will be prescribed and inserted by orthodontic postgraduate students under the supervision of fully qualified orthodontic specialists, or by orthodontists at private orthodontic practices.
Intervention code [1] 296121 0
Treatment: Devices
Comparator / control treatment
Orthodontic brackets to move teeth.

Control subjects-60 participants will be treated orthodontically using orthodontic brackets attached to the teeth. Plaque samples will be taken and analysed prior to the start of treatment and at 6 months of treatment. Presence of white spot tooth lesions (using the and gingivitis will be assessed at these 2 time periods.

The aligners will be prescribed and inserted by orthodontic postgraduate students under the supervision of fully qualified orthodontic specialists, or by orthodontists at private orthodontic practices.
Control group
Active

Outcomes
Primary outcome [1] 299865 0
The association between presence of individual bacterial taxa and the type of orthodontic appliance.

Collection of plaque from the labial surfaces of maxillary lateral incisors and 2nd premolars and the microbiota will be analysed and identified in the laboratory by ion semiconductor sequencing.
Timepoint [1] 299865 0
T0: Before treatment
T1: 6 months after commencement of treatment
Secondary outcome [1] 328334 0
To analyse the association of individual taxa with the presence or absence of gingivitis, comparing the type of the orthodontic appliance being used. This will be tested for by visual inspection of the gums using the 'Gingival Index' as described by Löe and Silness. The student researcher will be calibrated to carry out this index.
Timepoint [1] 328334 0
T0: Before treatment
T1: 6 months after commencement of treatment
Secondary outcome [2] 328335 0
To analyse the association of individual taxa with the presence or absence of dental white spot lesions, comparing the type of the orthodontic appliance being used. This will be tested for by visual inspection of the smooth surface of the teeth using the 'ICDAS II index'. The student researcher will be calibrated to carry out this index.
Timepoint [2] 328335 0
T0: Before treatment
T1: 6 months after commencement of treatment.

Eligibility
Key inclusion criteria
1) There is less than 8mm of crowding.
2) Patients have all permanent teeth present, except third molars and any necessary orthodontic extractions.
3) Demonstrate ability to maintain adequate oral hygiene.
4) Show optimum dental health without the immediate need for restorations.
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Skeletal anterior-posterior discrepancies between the maxilla and mandible (ANB below or equal to 5).
2) Centric relation (CR)- Centric occlusion (CO) discrepancies of greater than 3mm.
3) Anterior or posterior open bite.
4) Patients who are pregnant, diabetic, using mouth rinses or taking medications, including antibiotic therapy.
5) Presence of impacted teeth.
6) Presence of pre-treatment white spot lesions.
7) Presence of developmental defects of enamel i.e. Amelogenesis imperfecta, hypomineralisation.
8) Presence of active periodontal disease as evidenced by attachment loss.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed, as it is the patient themselves that will decide whether they want to be treated orthodontically with brackets or aligners.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 2 groups will have a 1:1 allocation. Computer software will be used to generate a stratified random sampling sequence for allocation to the right or left side of the maxillary arch, which will be concealed and disclosed to patients only once they have agreed to be a part of the study and have signed the consent form.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
There has not been any previous study comparing the microbiome present in the oral cavity of patients being treated with aligners vs brackets. Tanner et al studied the proportion of patients having a particular type of bacteria in the oral cavity with WSL (white spot lesions) vs without WSL and high gingivitis vs low gingivitis. There was a difference of 30% (70% of the patients with high gingivitis vs 40% of patients with low gingivitis) for some of the predominant bacteria, such as Prevotella Cluster IV. The calculation of the present sample size was based on the ability to detect a difference in the proportion of patients (having various types of bacteria in the oral cavity=primary outcome) of 30% between the aligner and the bracket groups (70% vs 40%) with a significance level of 0.05 and power of 80%. This calculation indicated that 49 participants were required in each arm; this was rounded up to a total of 120 to account for losses to follow-up.

Statistical analysis:

Primary Outcome: Logistic regression will be used to estimate association between presence of individual bacterial taxa and the type of orthodontic appliance.

Secondary Outcome: Logistic regression models will be fitted to analyse the association of individual taxa with presence or absence of gingivitis or WSL, adjusting for the type of the appliance being used.
Estimated odds ratios (ORs) and 95% confidence intervals (CIs) will be calculated, along with any P-values for any hypothesis tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/05/2017
Date of last participant enrolment
Anticipated
1/10/2019
Actual
Date of last data collection
Anticipated
1/05/2020
Actual
Sample size
Target
120
Accrual to date
116
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294691 0
Charities/Societies/Foundations
Name [1] 294691 0
Australian society of orthodontists foundation for research and education
Country [1] 294691 0
Australia
Primary sponsor type
University
Name
University of Melbourne, School of Dentistry
Address
720 Swanston street,
Carlton,
VIC 3053
Country
Australia
Secondary sponsor category [1] 293536 0
Individual
Name [1] 293536 0
Dr. Sachin Agarwal
Address [1] 293536 0
University of Melbourne-School of Dentistry,
720 Swanston Street,
Carlton,
VIC 3053
Country [1] 293536 0
Australia
Other collaborator category [1] 280214 0
Individual
Name [1] 280214 0
Dr Wayne Ly
Address [1] 280214 0
Melbourne dental school
Orthodontic department
720 Swanston st
Carlton
VIC 3053
Country [1] 280214 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296115 0
The University of Melbourne Office for research ethics and integrity
Ethics committee address [1] 296115 0
Ethics committee country [1] 296115 0
Australia
Date submitted for ethics approval [1] 296115 0
05/09/2016
Approval date [1] 296115 0
27/03/2017
Ethics approval number [1] 296115 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69610 0
Dr Sachin Agarwal
Address 69610 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston street,
Carlton,
VIC 3053
Country 69610 0
Australia
Phone 69610 0
+61424784575
Fax 69610 0
Email 69610 0
sachin.agarwal@unimelb.edu.au
Contact person for public queries
Name 69611 0
Dr John Bradley
Address 69611 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston street,
Carlton,
VIC 3053
Country 69611 0
Australia
Phone 69611 0
+61403932207
Fax 69611 0
Email 69611 0
jbradley2@student.unimelb.edu.au
Contact person for scientific queries
Name 69612 0
John Bradley
Address 69612 0
University of Melbourne
School of Dentistry, Orthodontic department
720 Swanston street,
Carlton,
VIC 3053
Country 69612 0
Australia
Phone 69612 0
+61403932207
Fax 69612 0
Email 69612 0
jbradley2@student.unimelb.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.