None listed
Conditions
Brief summary
There are many types of orthodontic appliances with the most common fixed appliance consists of brackets bonded onto the enamel of the teeth and wires that provide the force for tooth movement. The more recent method is with a series of customized clear appliances, called "aligners". The purpose of the study is to compare the outcomes Invisalign® System to the fixed orthodontic appliance; and especially for subjects who have moderate malocclusion (greater than 5mm of crowding in either the maxilla or the mandible). The secondary outcome measures are treatment efficiency and patient satisfaction.
Interventions
Participants are recruited from two private orthodontic practices in Melbourne, Australia. Each patient will be treated with clear aligners or fixed appliances.
All participants are treated by experienced specialist orthodontists. The clear aligner treatment (CAT) group will use Invisalign® aligners (Align® Technology Inc., San Jose, CA, USA). Invisalign® subjects’ treatment will include the most up-to-date features of the system including SmartTrackTM, SmartStagingTM and SmartForceTM includi
Participants are recruited from two private orthodontic practices in Melbourne, Australia. Each patient will be treated with clear aligners or fixed appliances. All participants are treated by experienced specialist orthodontists. The clear aligner treatment (CAT) group will use Invisalign® aligners (Align® Technology Inc., San Jose, CA, USA). Invisalign® subjects’ treatment will include the most up-to-date features of the system including SmartTrackTM, SmartStagingTM and SmartForceTM including BiteRampsTM, PrecisionCutsTM and Power RidgesTM. The Invisalign appliance is fitted by a specialist orthodontist at the start of treatment. Patients are advised to wear their aligners for approximately 22 hours daily. Aligners are to be removed for eating, drinking and brushing teeth. Each aligner will be worn for one week, and then replaced by the participant by the next in the series until the final one in the series was achieved. Participants are reviewed by the specialist orthodontist every 6-12 weeks with a minimum of 15 minute appointment, or as required. Compliance is measured by self-reporting. Total duration of treatment is the time required to correct the dental malocclusion. Intermaxillary elastics will be used as necessary. Potential participants who met the eligibility criteria were invited to participate in the study with appliance selection decision was made by the participant in collaboration with their treating orthodontist.
Sponsors
Australian Foundation for Orthodontic Research and Education
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: • Subjects with moderate malocclusion with 5mm of crowding in the mandibular or maxillary arch • Participant and/or parent signed consent form • Aged 12 years and older • Permanent dentition (except second or third molars)
Exclusion criteria
Exclusion criteria: • Active periodontal disease • Active dental caries • Known allergies to latex and / or plastic • Antero-posterior correction of greater than 4 mm • Subjects requiring molar and premolar extractions • Subjects requiring orthognathic surgery, combination of FA and CAT, use of accelerated tooth movement devices e.g., AcceleDent® (OrthoAccel® Technologies Inc., Houston, TX, USA) or the use of extra-oral anchorage e.g., headgear • Any condition making the subject unsuitable for orthodontic treatment
Outcome results
None listed