Abstract
Objectives
In 2013, a novel material SmartTrack® was introduced to replace the previous material used for Invisalign® aligners. We conducted this study to test how this transition was accepted by patients during ongoing Invisalign® treatment.
Methods
We surveyed a total of 72 patients (68 % women, 32 % men, mean age: 29.3 ± 9.2 years) who had worn the new material for a mean of 6 months. They completed a questionnaire with 25 items that compared both materials in terms of pain, pressure upon insertion, comfort, mucosal irritation, phonetics, discoloration, and taste.
Results
On a numerical rating scale (NRS) ranging from 0 to 10, the new aligner material was rated by the respondents to cause significantly (p < 0.001) less maximum pain than the old material (2.8 vs. 3.8). Significant reductions were obtained for duration of pain (p < 0.001) and duration of pressure (2.5 vs. 1.9 days; p = 0.001) upon insertion of the aligners. Over 90 % of the respondents indicated less or equal pain during eating, felt that the new material offered a tighter fit, and provided more favorable ratings for impairment, durability, and discoloration. Improved comfort was reported by 50 % of the respondents.
Conclusions
The new material was favorably rated by the patients and showed significant reductions in pain intensity, pain duration, and pressure upon insertion. Important clinical parameters like overall comfort and impairment also were improved. The clinical effectiveness of the new material remains to be investigated.
Zusammenfassung
Ziel
In der vorliegenden Arbeit sollte überprüft werden, wie Patienten mit Invisalign®-Behandlung den Umstieg vom herkömmlichen auf das seit 2013 gebräuchliche neue SmartTrack® Material einschätzen.
Patienten und Methoden
Insgesamt 72 Patienten im Durchschnittsalter von 29,3 ± 9,2 Jahren (68 % weiblich; 32 % männlich) beantworteten durchschnittlich 6 Monate nach dem Umstieg auf das neue Material einen Fragebogen mit 25 Items zu Schmerzen, Druck beim Einsetzen, Tragekomfort, Schleimhautirritationen, Sprachproblemen, Verfärbungen und Geschmack, um die beiden Materialien miteinander zu vergleichen.
Ergebnisse
Die Patienten geben mit dem neuen Aligner-Material signifikant verringerte maximale Schmerzen an (NRS, numerische Ratingskala, 2,8 vs. 3,8; p < 0,001). Zusätzlich waren Schmerzdauer (p < 0,001) und Dauer des Drucks nach dem Einsetzen signifikant geringer (1,9 vs. 2,5 Tage; p = 0,001). Weiterhin gaben über 90 % der Patienten weniger oder unveränderte Schmerzen beim Essen an, sie empfanden das neue Material als enger oder gleich anliegend und bewerteten es als besser oder gleich gut hinsichtlich Beeinträchtigungen, Haltbarkeit und Verfärbungen. Der Tragekomfort wurde von 50 % der Befragten als verbessert angegeben.
Diskussion
Das neue Material wurde von den Patienten positiv bewertet, da es signifikant zu reduzierter Schmerzstärke, kürzerer Schmerzdauer und zu geringerem Druck beim Einsetzen der Schienen führte. Auch bei weiteren klinisch relevanten Parametern wie Tragekomfort und Beeinträchtigungen, zeigten sich Verbesserungen. Eine Prüfung hinsichtlich der klinischen Effektivität steht noch aus.
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A.K. Bräscher, R.E. Feldmann, Jr., and J. Benrath declare that they have no competing interests. D. Zuran is clinical speaker for Invisalign®, including giving seminars and certifications for the Invisalign® technique.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
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A.-K. Bräscher and D. Zuran contributed equally to the manuscript.
An erratum to this article is available at http://dx.doi.org/10.1007/s00056-016-0081-x.
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Bräscher, AK., Zuran, D., Feldmann, R.E. et al. Patient survey on Invisalign® treatment comparen the SmartTrack® material to the previous aligner material. J Orofac Orthop 77, 432–438 (2016). https://doi.org/10.1007/s00056-016-0051-3
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DOI: https://doi.org/10.1007/s00056-016-0051-3