Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
313026
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dental malocclusion
335322
0
Query!
Orthodontic relapse
335245
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
331799
331799
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329575
0
Prevention
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
339435
0
Little's Irregularity Index (mandibular incisor crowding)
Query!
Assessment method [1]
339435
0
Scans (not xrays) will be taken of each patients dentition at the fixed retainer binding appointment, then at 3 months, 6 months, 12 months and 24 months. 3Shape software will be used to measure the lower incisor contact point displacement using digital models.
Query!
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.
Query!
Secondary outcome [1]
440256
0
Plaque accumulation
Query!
Assessment method [1]
440256
0
Assessed clinically using the Greene-Vermillion Index. Each tooth will be assigned a score of: 0: No debris or stain present. 1: Soft debris covering not more than one third of the tooth surface, or presence of extrinsic stains without other debris regardless of surface area covered. 2: Soft debris covering more than one third but not more than two thirds of the exposed tooth surface. 3: Soft debris covering more than two thirds of the exposed tooth surface. The score for each tooth will be added together to give a total score for each arch for each patient.
Query!
Timepoint [1]
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
Query!
Secondary outcome [2]
440257
0
Calculus accumulation
Query!
Assessment method [2]
440257
0
Assess clinically using the Greene-Vermillion Index. Each tooth will be scored: 0: No calculus present. 1: Supra-gingival calculus covering not more than one third of the exposed tooth surface. 2: Supra-gingival calculus covering more than one third but not more than two thirds of the exposed tooth surface, or the presence of individual flecks of sub-gingival calculus around the cervical portion of the tooth or both. 3: Supra-gingival calculus covering more than two thirds of the exposed tooth surface, or a continuous heavy band of sub-gingival calculus around the cervical portion of the tooth, or both. Scores for each tooth will be added to form a total for each arch.
Query!
Timepoint [2]
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.
Query!
Secondary outcome [3]
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.
Query!
Assessment method [3]
439970
0
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 (which teeth are rebonded) or need for replacement at each recall appointment at 3 months, 6 months, 12 months and 24 months.
Query!
Timepoint [3]
439970
0
At 3 months, 6 months, 12 months, and 24 months post-initiation of bonding fixed retainers.
Query!
Secondary outcome [4]
439971
0
Intercanine width
Query!
Assessment method [4]
439971
0
Scans (not xrays) will be taken of each patients dentition at the fixed retainer bonding appointment, then at 3 months, 6 months, 12 months and 24 months. 3Shape software will be used to measure the distance between the cusp tips of the canine teeth in each arch using digital models.
Query!
Timepoint [4]
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.
Query!
Secondary outcome [5]
439975
0
Patient satisfaction
Query!
Assessment method [5]
439975
0
Assessed via means of a questionnaire addressing cleaning, eating, talking and general wear. The patient will be asked to score 6 questions out of 100, where 0 indicates complete dissatisfaction and 100 is complete satisfaction. The answers for each question will be considered individually, and a total combined result for each patient questionnaire. The questionnaire is based on a similar study performed by Gera et al. (2023). Participants will be asked to complete the questionnaire at each recall appointment at 3 months, 6 months, 12 months and 24 months.
Query!
Timepoint [5]
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.
Query!
Secondary outcome [6]
439972
0
Intermolar width
Query!
Assessment method [6]
439972
0
Scans (not xrays) will be taken of each patients dentition at the fixed retainer binding appointment, then at 3 months, 6 months, 12 months and 24 months. 3Shape software will be used to measure the distance between the palatal cusp tips first molar teeth in each arch using digital models.
Query!
Timepoint [6]
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.
Query!
Secondary outcome [7]
439973
0
Arch depth
Query!
Assessment method [7]
439973
0
Scans (not xrays) will be taken of each patients dentition at the fixed retainer binding appointment, then at 3 months, 6 months, 12 months and 24 months. 3Shape software will be used to digitally draw a line between the palatal cusp tips of the first molar teeth in each arch. The distance between a line running perpendicular to the line between the first molars to the contact point of the central incisors in each arch will be used to represent arch depth.
Query!
Timepoint [7]
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.
Query!
Secondary outcome [8]
439974
0
Periodontal probing depths
Query!
Assessment method [8]
439974
0
Periodontal probing will be recorded at 6 sites per tooth on the six maxillary and mandibular anterior teeth to assess pocket depth
Query!
Timepoint [8]
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.
Query!
Secondary outcome [9]
440255
0
Bleeding on probing.
Query!
Assessment method [9]
440255
0
Periodontal probing will be completed on the six maxillary and mandibular anterior teeth to calculate the percentage of sites with bleeding on probing (6 sites per tooth) will be collected at the end of treatment/beginning of retention, and at each recall appointment at 3 months, 6 months, 12 months and 24 months.
Query!
Timepoint [9]
440255
0
At each recall appointment post-bonding of fixed retainers at 3 months, 6 months, 12 months and 24 months.
Query!
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
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
25
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/03/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
30/04/2027
Query!
Actual
Query!
Sample size
Target
50
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
27138
0
Sydney Dental Hospital - Surry Hills
Query!
Recruitment postcode(s) [1]
43215
0
2010 - Surry Hills
Query!
Funding & Sponsors
Funding source category [1]
317467
0
Charities/Societies/Foundations
Query!
Name [1]
317467
0
Australian Society of Orthodontists
Query!
Address [1]
317467
0
Query!
Country [1]
317467
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Sydney Local Health District
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
319756
0
None
Query!
Name [1]
319756
0
Query!
Address [1]
319756
0
Query!
Country [1]
319756
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316181
0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Query!
Ethics committee address [1]
316181
0
https://www.slhd.nsw.gov.au/rpa/research/
Query!
Ethics committee country [1]
316181
0
Australia
Query!
Date submitted for ethics approval [1]
316181
0
26/08/2024
Query!
Approval date [1]
316181
0
22/11/2024
Query!
Ethics approval number [1]
316181
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
137054
0
Dr Oyku Dalci
Query!
Address
137054
0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Query!
Country
137054
0
Australia
Query!
Phone
137054
0
+61283360625
Query!
Fax
137054
0
Query!
Email
137054
0
[email protected]
Query!
Contact person for public queries
Name
137055
0
Dr. Megan Collins
Query!
Address
137055
0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Query!
Country
137055
0
Australia
Query!
Phone
137055
0
+61 415594597
Query!
Fax
137055
0
Query!
Email
137055
0
[email protected]
Query!
Contact person for scientific queries
Name
137056
0
Dr. Megan Collins
Query!
Address
137056
0
Sydney Dental Hospital, 2 Chalmers st, Surry Hills, NSW, 2010
Query!
Country
137056
0
Australia
Query!
Phone
137056
0
+61 415594597
Query!
Fax
137056
0
Query!
Email
137056
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF