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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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618002022246
Enrollment
19
Registered
2018-12-17
Start date
2019-02-19
Completion date
Unknown
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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. Adh

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

Sponsors

Australian Foundation for Orthodontic Research and Education
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

(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 criteria

Patient receiving a fixed retainer

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026