RecruitingACTRN12618002022246

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.


Sponsor

Australian Foundation for Orthodontic Research and Education

Enrollment

28 participants

Start Date

Feb 19, 2019

Study Type

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

Sex: Both males and femalesMin Age: 15 Yearss

Plain Language Summary

Simplified for easier understanding

After orthodontic treatment like Invisalign, retainers are worn to keep teeth in their new positions. This study compares two different types of clear plastic retainer materials to find out which one lasts longer and works better. It also tests whether wearing retainers only at night is just as effective as wearing them full-time — which could make life easier and potentially extend how long the retainers last before needing replacement. Participants will be randomly assigned to one type of retainer material and one wearing schedule, then followed for six months. The researchers will assess how many retainers survive intact (without breaking or distorting), whether teeth stay in position, and whether bite alignment settles naturally over time. You may be eligible if you are aged 15 or over, have just completed at least nine months of Invisalign treatment, have all your permanent teeth (except wisdom teeth), and have been prescribed removable retainers only — no fixed wire retainer behind your teeth. This is an Australian study run through an orthodontic research foundation.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 pr

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)

VIC, Australia

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ACTRN12618002022246


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