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Trial registered on ANZCTR


Registration number
ACTRN12625000025437
Ethics application status
Approved
Date submitted
21/09/2024
Date registered
15/01/2025
Date last updated
15/01/2025
Date data sharing statement initially provided
15/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of computer automated design and computer automated manufactured
(CAD/CAM)-based fixed retainers versus conventional fixed retainers: A randomised clinical trial
Scientific title
CAD/CAM fixed retainers versus conventional fixed retainers in preventing mandibular incisor relapse in adolescent and young adult orthodontic patients: A randomised clinical trial
Secondary ID [1] 313026 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthodontic relapse 335245 0
Dental malocclusion 335322 0
Condition category
Condition code
Oral and Gastrointestinal 331799 331799 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
CAD/CAM robot bent fixed retainers are glued to the back of the front teeth to stop them from moving after active orthodontic treatment with braces. They remain in place indefinitely after removing braces. They take approximately 30 minutes or less to bond and the process is painless. Vacuum formed retainers (clear retainers) also need to be worn at night indefinitely to hold the position of the back teeth and in case of breakages of the fixed retainer.
Prior to completion of active orthodontic treatment, eligible Sydney Dental Hospital patients will be informed about the study and if interested, will be included in the study. Participants will be randomised into either the CAD/CAM custom robot bent group or the conventional Ortho FlexTech group using the REDCap randomization module. Deidentified intra-oral scans (not xrays) will be taken prior to debanding (removing braces) for the CAD/CAM custom robot bent group and sent digitally to an offsite YOAT Bender II™ machine. The fixed retainers will be bonded within 7 days of scanning. The fixed retainers will be bonded by the investigators, who are qualified dental professionals.
All patients will also receive vacuum formed removable retainers. Participants will be instructed to wear upper and lower vacuum formed retainers overnight, to further reduce the risk of relapse (1). Removable retainers will need to be worn indefinitely. Participants will be recalled at 3 months, 6 months, 12 months and 24 months. New scans, clinical assessment, photos and patient questionnaires will be completed at each recall interval. 3D digital models that are created using intraoral scans will be compared to assess changes.
Intervention code [1] 329575 0
Prevention
Comparator / control treatment
The Ortho FlexTech group is the comparator/control group. Orthoflex Tech is a metal chain which is glued to the back of the front teeth after the completion of active orthodontic treatment. It takes approximately 30 minutes to bond and is painless. It stays in position indefinitely.
Prior to completion of active orthodontic treatment, eligible Sydney Dental Hospital patients will be informed about the study and if interested, will be included in the study. Participants will be randomised into either the CAD/CAM custom robot bent group or the conventional Ortho FlexTech group using the REDCap randomization module. For the conventional Ortho FlexTech group, the retainers will be bonded directly to the teeth. The fixed retainers will be bonded by the investigators, who are qualified dental professionals. All patients will also receive vacuum formed removable retainers. Participants will be instructed to wear upper and lower vacuum formed retainers overnight, to further reduce the risk of relapse (1). Removable retainers will need to be worn indefinitely. Participants will be recalled at 3 months, 6 months, 12 months and 24 months. New scans, clinical assessment, photos and patient questionnaires will be completed at each recall interval. 3D digital models that are created using intraoral scans will be compared to assess changes.
Control group
Active

Outcomes
Primary outcome [1] 339435 0
Little's Irregularity Index (mandibular incisor crowding)
Timepoint [1] 339435 0
At the same appointment as bonding the fixed retainer, and at 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [1] 439970 0
Survival: Assessed clinically, the mode of failure will be recorded (debonding at the wire composite interface, debonding at the composite enamel interface, wire fracture, unexpected tooth movement) as well as the method of repair or need for replacement at each recall appointment at 3 months, 6 months, 12 months and 24 months.
Timepoint [1] 439970 0
At 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [2] 439971 0
Intercanine width
Timepoint [2] 439971 0
At the same appointment as bonding the fixed retainer, and at 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [3] 439972 0
Intermolar width
Timepoint [3] 439972 0
At the same appointment as bonding the fixed retainer, and at 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [4] 439973 0
Arch depth
Timepoint [4] 439973 0
At the same appointment as bonding the fixed retainer, and at 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [5] 439974 0
Periodontal probing depths
Timepoint [5] 439974 0
At the same appointment as bonding the fixed retainer, and at 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Secondary outcome [6] 439975 0
Patient satisfaction
Timepoint [6] 439975 0
Participants will be asked to complete the questionnaire at each recall appointment post-bonding fixed retainers at 3 months, 6 months, 12 months and 24 months.
Secondary outcome [7] 440255 0
Bleeding on probing.
Timepoint [7] 440255 0
At each recall appointment post-bonding of fixed retainers at 3 months, 6 months, 12 months and 24 months.
Secondary outcome [8] 440256 0
Plaque accumulation
Timepoint [8] 440256 0
Measurements will be taken at each recall appointment at 3 months, 6 months, 12 months and 24 months post-bonding of fixed retainers
Secondary outcome [9] 440257 0
Calculus accumulation
Timepoint [9] 440257 0
Measurements will be taken at recall appointments at 3 months, 6 months, 12 months and 24 months post-initiation of bonding of fixed retainers.

Eligibility
Key inclusion criteria
Good general health
Age range 12-25 years old
Presence of all maxillary and mandibular anterior teeth with normal shape and size
Completion of comprehensive orthodontic treatment with full fixed appliances
The patient/guardian has agreed to the choice of retainer
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Craniofacial syndrome
Poor oral hygiene or periodontal compromise
Active caries, enamel defects, or any other structural compromise to the anterior teeth
Patients who were recommended for a different retention protocol

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)
Participants will be randomised into either the CAD/CAM custom robot bent group or the conventional Ortho FlexTech group using the REDCap randomization module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into either the CAD/CAM custom robot bent group or the conventional Ortho FlexTech group using the REDCap randomization module.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27138 0
Sydney Dental Hospital - Surry Hills
Recruitment postcode(s) [1] 43215 0
2010 - Surry Hills

Funding & Sponsors
Funding source category [1] 317467 0
Charities/Societies/Foundations
Name [1] 317467 0
Australian Society of Orthodontists
Country [1] 317467 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319756 0
None
Name [1] 319756 0
Address [1] 319756 0
Country [1] 319756 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316181 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316181 0
https://www.slhd.nsw.gov.au/rpa/research/
Ethics committee country [1] 316181 0
Australia
Date submitted for ethics approval [1] 316181 0
26/08/2024
Approval date [1] 316181 0
22/11/2024
Ethics approval number [1] 316181 0

Summary
Brief summary
Hypothesis: There is no difference between computer automated designed and computer automated manufactured (CAD-CAM) based fixed bonded metal orthodontic retainers used to hold tooth positions after active orthodontic treatment and conventional, non-customised bonded fixed retainers.
At the completion of orthodontic treatment, patients are provided with orthodontic retainers to keep their teeth and bite stable, and to prevent relapse of teeth back into their pre-treatment positions. Fixed retainers are advantageous due to their lack of reliance on patient compliance; however they do suffer a high rate of failure. The popularity of chairside CAD/CAM wire bending robot machines is increasing due to their ease of use and fast turnaround time. The aim of the study is to compare computer-aided design and computer-aided manufacturing (CAD/CAM) custom robot bent fixed orthodontic retainers to conventional Ortho FlexTech direct bonded fixed retainers in terms of orthodontic treatment stability by means of a prospective, randomised clinical trial. Additionally, secondary objectives are to assess and compare patient satisfaction, survivability, cleansibility and periodontal health with each type of bonded retainer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137054 0
Dr Oyku Dalci
Address 137054 0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Country 137054 0
Australia
Phone 137054 0
+61283360625
Fax 137054 0
Email 137054 0
[email protected]
Contact person for public queries
Name 137055 0
Dr. Megan Collins
Address 137055 0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Country 137055 0
Australia
Phone 137055 0
+61 415594597
Fax 137055 0
Email 137055 0
[email protected]
Contact person for scientific queries
Name 137056 0
Dr. Megan Collins
Address 137056 0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Country 137056 0
Australia
Phone 137056 0
+61 415594597
Fax 137056 0
Email 137056 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?

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.