Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers

Study Overview
=================
Brief Summary
-----------------
This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).

Official Title
-----------------
Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial

Conditions
-----------------
Orthodontic Retention Compliance

Intervention / Treatment
-----------------
* Other: orthodontic appliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch age 12- 18 Exclusion Criteria: systematic diseases craniofacial anomalies (clefts, etc) handicapped patients with problems of compliance pregnant women previous orthodontic treatment or compromise orthodontic treatment

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermoplastic Retainer<br>Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. | Other: orthodontic appliance<br>* Orthodontic device for retention in the upper arch, after the end of orthodontic treatment<br>|
| Active Comparator: Hawley Retainer<br>Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day. | Other: orthodontic appliance<br>* Orthodontic device for retention in the upper arch, after the end of orthodontic treatment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of retainer wear | Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of retainer wear | Compliance of retainer wear at 1 month, as expressed by average hours of daily wear (with the aid of TheraMon) | 1 month | 
| Association between objective compliance assessment and diary reported hours | Association between objective compliance assessment (TheraMon) and diary reported hours (by patient) | 3 months | 
| Association between objective compliance assessment and diary reported hours | Association between objective compliance assessment (TheraMon) and diary reported hours (by patient) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hawley, thermoplastic, orthodontic retention, compliance, vacuum- formed