Unit:
Κατεύθυνση Ορθοδοντική (Κλινικές Ειδικεύσεις)Βιβλιοθήκη Οδοντιατρικής
Supervisors info:
Ηλίας Μπιτσάνης, Επίκουρος Καθηγητής, Τμήμα Οδοντιατρικής, Σχολή Επιστημών Υγείας, ΕΚΠΑ
Δημήτριος Χαλαζωνίτης, Καθηγητής, Τμήμα Οδοντιατρικής, Σχολή Επιστημών Υγείας, ΕΚΠΑ
Ελένη Βασταρδή, Επίκουρη Καθηγήτρια, Τμήμα Οδοντιατρικής, Σχολή Επιστημών Υγείας, ΕΚΠΑ
Original Title:
Objective evaluation of compliance after orthodontic treatment using Hawley or Vacuum- formed retainers. A two- center randomized controlled trial over a three- month period
Translated title:
Objective evaluation of compliance after orthodontic treatment using Hawley or Vacuum- formed retainers. A two- center randomized controlled trial over a three- month period.
Summary:
Introduction: The aim of this 2- arm parallel trial was to objectively assess patients’ compliance, in a 3 month period, with Hawley or vacuum-formed retainers in the upper arch, after active orthodontic treatment, through the use of the thermosensitive microsensor TheraMon®.
Methods: Patients who had just completed their orthodontic treatment in the Postgraduate Orthodontic Clinic, School of Dentistry, National and Kapodistrian University of Athens and in a private orthodontic practice, were randomly allocated to either Hawley or vacuum-formed group for retention. Eligibility criteria included patients 12- 18 years of age who had undergone orthodontic treatment in both arches, for no longer than 5 years. The main outcome was the average objective daily difference in compliance measured with TheraMon®, between patients receiving either Hawley or vacuum-formed retainers in the maxillary arch for a period of 3 months. Secondary outcomes pertained to the average objective difference in compliance between the two retainers for the first month in retention and the association between objective measurements of compliance and diary- reported wearing duration times for both the first and the 3- month period. Randomization was implemented with a computer-generated randomization list, with allocation concealed in sequentially numbered, sealed, opaque envelopes. Blinding was not feasible either for the patient or the orthodontist. Patients were instructed to wear the retainer full-time. Data were analyzed using non-parametric statistics, and linear regression with standard errors based on the bootstrap method. Results: Seventy- seven patients (median age: 14.8 years; interquantile range- IQR: 1.5; range: 12.1- 17.6) were randomized in a 1:1 ratio to either Hawley or vacuum- formed retainer. Baseline characteristics did not present significant differences between groups and one patient from Hawley group was excluded from 3 months follow-up due to microsensor fault. Objectively assessed median daily wear time for the Hawley group was 15.3 hours (IQR: 6.8), while for the Vacuum- formed group 18.3 hours (IQR: 4.6) for the 3 months interval. Patients allocated to vacuum-formed retainers, presented higher wearing values of 2.10 hours/day compared to Hawley group, after adjusting for trial settings(mean difference: 2.10; 95% Confidence Interval [CI]: 0.32- 3.89; p=0.02). Patients from private orthodontic practice presented an increased potential for compliance of 2.16 hours/day compared to University settings after adjusting for type of appliance (mean difference: 2.16; 95% Confidence Interval [CI]: 0.34- 3.97; p=0.02). A significant correlation was detected between objective assessment and self-reported compliance for both retention protocols in the first and 3 months interval. No harm was observed during the follow- up period. Conclusion: The results of this study indicate relatively high compliance in short- term retention phase for both appliances. Vacuum- formed retainers were better accepted by adolescent patients, while those proceeding to private orthodontic practice were more compliant. There was a positive and statistically significant correlation between objective and subjective measures of compliance.
Registration: The trial was registered in ClinicalTrials.gov: NCT03683862
Protocol: The protocol was not published before trial commencement.
Funding: No funding or conflict of interest to be declared.
Main subject category:
Health Sciences
Keywords:
Retention, Microsensors, Compliance of patients
File:
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GVagdouti_Thesis 12,11.pdf
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