None listed
Conditions
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.
Interventions
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
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.
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No
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
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
Outcome results
None listed