Comparative assessment of survival, stability and occlusal settling between full-time and part-time wear regime of two types of thermoplastic retainers: A randomised controlled clinical trial
Comparative assessment of the survival rate of two types of thermoplastic retainers in patients that have undergone clear aligner therapy.
Australian Foundation for Orthodontic Research and Education
28 participants
Feb 19, 2019
Interventional
Conditions
Summary
This study will compare two types of thermoplastic retainer materials in terms of their survival rate over a 6month period. It is hypothesised that one of these materials will show an improved survival rate when compared with the other. Secondary outcomes to be assessed include occlusal stability and occlusal settling. These outcomes will be assessed for two different wear regimes (ie; Full time vs Full time; Night time vs Night time) to see whether this significantly impacts on the results. If the retainer types deliver similar occlusal stability and occlusal settling results regardless of the wear regime (as previous research has suggested), then it is hypothesised that survival rate may be improved by only having a night time only wear regime. This would then enable the thermoplastic retainers to have a longer lifespan resulting in less cost for patients/practitioners.
Eligibility
Inclusion Criteria5
- (1) Participant is over 15 years of age
- (2) Participant and/or parent signed consent form
- (3) Full permanent dentition present, excluding second and third molar teeth
- (4) Completed Invisalign for minimum of 9 months
- (5) Been prescribed upper and lower removable retainers only (no fixed retainer)
Exclusion Criteria1
- Patient receiving a fixed retainer
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Interventions
Participants will be recruited from a private orthodontic practice located in Melbourne. Each patient will already have their retainer type (ie; Vivera® or Duran®) assigned in accordance with their preference. If they consent to be included in the study, they will then be randomly allocated in to either the full time (minimum 20hours of wear per day) or night time (Minimum 8hours and maximum 10hours) wear regime group for their respective retainer material and followed over a 6 month period. Adherence to the wear regime will be patient reported. The retainers and their care instructions will be delivered in person by specialist orthodontists with over 10years experience. In summary, Four patient groups: Vivera® - Full time and Night Time groups within this Duran® - Full time and Night Time groups within this Observation Period of 6 months - T0: Intra-oral scan for retainer manufacturing - T1: Insert retainers and begin observation period - T2: 8 week review including intra-oral scan - T3: 6 month review including intra-oral scan Primary Outcome: Survival rate compared between Vivera® and Duran®. This will be assessed for both a full time and night time only wear regime. Secondary Outcome/s: Occlusal stability and occlusal settling
Locations(1)
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ACTRN12618002022246