 An occasionally irregular blog about orthodontics The quantity and quality of research into clear aligners seems to be improving. This post is about a well-conducted, new randomised trial of monitoring the wear time of orthodontic aligners. It provides useful information on the effect of informing patients that we monitor the time that they wear their aligners.
A team from Munich, Germany, did this study. The AJODO published the paper.
What did they ask?
They did this study to;
“Objectively assess the wear time of aligners using micro sensors and to evaluate whether patient awareness of monitoring affects wear time.”
What did they do?
They conducted a prospective, single-centre, two-arm, parallel, randomised controlled trial with a 1:1 allocation ratio.
The PICO was…
Participants
Orthodontic patients treated in a university clinic requiring treatment for crowding or spacing.
Intervention
“Aware group” Theramon orthodontic wear timer. The operator told this group of patients about the monitoring.
Comparison
This group also had Theramon times they did not inform them that they were being monitored
Outcome
The primary outcome was wear time (hours/day).
The operators reviewed the patients every 14 days for 6 appointments. This corresponded to a period of approximately 12 weeks. They asked the patients to wear their aligners for 22 hours/day.
They measured appliance wear time by recording temperature with a Theramon microsensor embedded in the aligner material.
The statistician conducted a clear sample size calculation indicating that 40 participants were required for the study.
The team used a prepared randomisation, and allocation was done by using sealed envelopes.
Data analysis was done blind.
They conducted a clear and relevant data analysis using exploratory statistics and multivariate analyses, with wear time as the dependent variable.
What did they find?
They randomised 43 patients into the two groups. Three discontinued the intervention, leaving 40 patients in the final analysis.
When they examined the wear time of the aligners, they found substantial individual variation.
The daily wear time ranged from 1.5 to 22.5 h/day, with a mean of 13.7 h/day in the monitoring unaware group and 5.8-21.8 h/day (mean 16.7 h/day) in the monitoring aware group. The overall mean wear time was 15.2 h/day, representing 67% of the required time.
The wear time of subjects in the “aware” group was, on average, 4.4 h/day longer than that of subjects in the “unaware” group (95% CI 1.88 to 6.93).
Their overall conclusion was
“Awareness of monitoring improved patient compliance and can be used as an effective strategy to enhance WT during aligner therapy in adults”.
What did I think?
This was a well-conducted and clearly written study. It was great to see that the authors had followed the CONSORT guidelines very closely, which made the interpretation of their study relatively straightforward. The paper is also open access, so anyone can read it. It was refreshing to see such a nicely done piece of work.
I thought the findings were interesting and clinically relevant. In many respects, these findings are similar to those of other studies that used timers for removable appliances. Importantly, this reflects the “real-world” experience of removable appliance wear and reinforces the finding that our patients rarely adhere to our wear time recommendations. Importantly, this study suggested that the results of part time wear of Twin Blocks was not differerent than full time wear.
It also strongly suggests that informing patients of monitoring will increase compliance with our instructions. This is a very useful conclusion. Importantly, the Theramon timer is a minute-by-minute timer and is more accurate than the Invisalign compliance indicato which is a visual aid for compliance.
I hope that the team will continue their study through the end of treatment. This would provide valuable information on the effect of wear time on the final clinical outcomes.
I hope that research teams are conducting further studies on aligners to this standard.
The post This is a great study on the influence of monitoring timers on aligner wear time. appeared first on Kevin O'Brien's Orthodontic Blog.
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