Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000612516
Ethics application status
Approved
Date submitted
21/05/2015
Date registered
12/06/2015
Date last updated
12/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A new toothbrushing technique for patients with orthodontic braces.
Scientific title
A new toothbrushing technique to enhance oral hygiene in patients with fixed appliances.
Secondary ID [1] 286693 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral hygiene 295047 0
Condition category
Condition code
Oral and Gastrointestinal 295301 295301 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
Intervention group will be taught the orthodontic toothbrushing technique, which is designed by combining the horizontal strokes and a bite and wiggle motion behind arch wires.
Briefly, the toothbrush was firstly placed gingival to the brackets and angled 45 degrees towards the occlusal surface. The same motion was repeated with the bristles perpendicular to the labial surface of the brackets. Lastly, with the toothbrush perpendicular to the occlusal area of the brackets, the individual was asked to bite and wiggle. By biting on the toothbrush head, bristles entered into the space behind the arch wires and between the brackets.

An orthodontist will teach the toothbrushing techniques to participants during individual consultation at baseline. Each participants will be required to brush their teeth for 2 minutes and twice daily (in the morning and before sleeping) for 3 months. Patient's compliance will be assessed and monitored by checking the wear of their toothbrushes.
Intervention code [1] 291926 0
Prevention
Comparator / control treatment
Control group will be taught the traditional Modified Bass toothbrushing technique for oral hygiene.
An orthodontist will teach this toothbrushing techniques to participants during individual consultation at baseline. Each participants will be required to brush their teeth for 2 minutes and twice daily (in the morning and before sleeping) for 3 months.
Control group
Active

Outcomes
Primary outcome [1] 295125 0
Plaque index
Timepoint [1] 295125 0
The 1st month, 2nd month, and 3rd month after the interventions.
Primary outcome [2] 295126 0
Gingival index
Timepoint [2] 295126 0
The 1st month, 2nd month, and 3rd month after the interventions.
Secondary outcome [1] 314819 0
Bracket bond failure will be be recorded if the bracket is debonded from the enamel during the trial.
Timepoint [1] 314819 0
The 1st month, 2nd month, and 3rd month after the interventions.

Eligibility
Key inclusion criteria
1. aged between 11 and 40 years,
2. undergoing orthodontic treatment with fixed appliances,
3. residual treatment duration of at least 3 months,
4. presence of 20 natural teeth or more.
Minimum age
11 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. fixed lingual orthodontic appliances,
2. systemic diseases that may affect oral hygiene or gingival health,
3. periodontal disease,
4. extensive dental restorations.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A balanced block randomisation will be generated by computer and concealed in an opaque envelope.
Investigator who will conduct the measurements will be blinded to the group allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using SPSS (version 22.0. for Macintosh; IBM Corp.; Armonk, NY). An intention-to-treat analysis will be carried out, with a–error set to 0.05, using the Mann-Whitney U test to compare Plaque Index and Gingival Index at the baseline; and the Wilcoxon test will be used to assess Plaque Index and Gingival Index reduction at different time points.

The calculation of sample size is based on previous estimates of plaque index variability (standard deviation = 0.4), of a similar population group requiring orthodontic treatment. With a-error set to 0.05 and ß error set to 0.20 (80% power), a total of 29 participants were required for each group to detect a plaque index reduction of 0.25. We aim to recruit a total of 60 participants based on these parameters and accounting for the possible dropouts during the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2014
Actual
4/08/2014
Date of last participant enrolment
Anticipated
Actual
29/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 6892 0
New Zealand
State/province [1] 6892 0
Dunedin

Funding & Sponsors
Funding source category [1] 291317 0
University
Name [1] 291317 0
Faculty of Dentistry, University of Otago
Country [1] 291317 0
New Zealand
Primary sponsor type
University
Name
Faculty of Dentistry, University of Otago
Address
310 Great King Street, Dunedin, 9016.
Country
New Zealand
Secondary sponsor category [1] 289997 0
None
Name [1] 289997 0
Address [1] 289997 0
Country [1] 289997 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292880 0
University of Otago Ethics Committee
Ethics committee address [1] 292880 0
362 Leith Street, Dunedin, 9016
Ethics committee country [1] 292880 0
New Zealand
Date submitted for ethics approval [1] 292880 0
01/04/2014
Approval date [1] 292880 0
19/05/2014
Ethics approval number [1] 292880 0
H14/060

Summary
Brief summary
Traditional tooth brushing techniques, such as the Modified Bass technique, are designed and aimed at the general population without orthodontic appliances. An effective tooth brushing technique for patients wearing orthodontic fixed appliances is still lacking.

We will design an Orthodontic tooth brushing technique to enhance the oral hygiene of patients with fixed orthodontic appliances, and compare its efficacy with that of the traditional Modified Bass technique.

This study will be conducted as a single blind randomised controlled clinical trial with two parallel arms. We will aim to recruit 60 patients. Plaque index (PI) and Gingival index (GI) will be used to assess the oral hygiene of participants. Outcome measurements will be taken at baseline (T0) and one-month (T1), two-month (T2), and three-month (T3) after the intervention.
Trial website
Trial related presentations / publications
A Master thesis has been completed based on this trial.
Title of the thesis: An orthodontic tooth brushing technique to enhance oral hygiene in patients with fixed appliances: interim results of a randomized controlled clinical trial.
Author: Austin Kang.
Supervisor: Mauro Farella and Li Mei.
University: Faculty of Dentistry, University of Otago.
Date: March 2015.
Public notes

Contacts
Principal investigator
Name 57202 0
Dr Li Mei
Address 57202 0
Department of Oral Sciences, Faculty of Dentistry, University of Otago. 310 Great King Street, Dunedin, 9016
Country 57202 0
New Zealand
Phone 57202 0
+64 3 479 7480
Fax 57202 0
Email 57202 0
[email protected]
Contact person for public queries
Name 57203 0
Dr Li Mei
Address 57203 0
Department of Oral Sciences, Faculty of Dentistry, University of Otago. 310 Great King Street, Dunedin, 9016
Country 57203 0
New Zealand
Phone 57203 0
+64 3 479 7480
Fax 57203 0
Email 57203 0
[email protected]
Contact person for scientific queries
Name 57204 0
Dr Li Mei
Address 57204 0
Department of Oral Sciences, Faculty of Dentistry, University of Otago. 310 Great King Street, Dunedin, 9016
Country 57204 0
New Zealand
Phone 57204 0
+64 3 479 7480
Fax 57204 0
Email 57204 0
[email protected]

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
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